510(k) · Cleared
Recalled · Class I · 2026Allura Xper FD series and Allura Xper OR Table series
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems Nederland B.V. · OWB Interventional Fluoroscopic X-Ray System
Cleared on Dec 2, 2016 as substantially equivalent to K161563 (Philips Medical Systems Nederland B.V., 2016) after a 51-day review. Its family tree reaches back 13 generations to 1980. 2 of the 56 devices in its family, counting itself, have a Class I recall. 1 later device descends from it. It has been recalled 36 times, including 12 Class I recalls.
- Decided
- Dec 2, 2016
- Review
- 51 days
- Class
- Class II
- Product code
- OWB
- Recalls
- 36 (12 Class I)
- Predicates
- 1
Its longest line of descent runs back 13 generations to K801623 (1980). 54 ancestors in all. 1 later device descends from it, 1 citing it directly. 2 of the 56 devices in this family, counting this one, have a Class I recall.
- Root · 13 generations backK801623 Cavitron Ultrasonic Surg. Aspir. CusaCavitron Corp. · 1980
- 9 generations between
- 3 generations backK133292 Allura Xper FD; or TablePhilips Medical Systems Nederland B.V. · 2014 · Recalled
- 2 generations backK141979 Allura Xper FD Series / Allura Xper or Table SeriesPhilips Medical Systems Netherland BV · 2014 · Recalled
- 1 generation backK161563 Allura Xper FD series and Allura Xper OR Table seriesPhilips Medical Systems Nederland B.V. · 2016 · Recalled
- This deviceK162859 Allura Xper FD series and Allura Xper OR Table seriesPhilips Medical Systems Nederland B.V. · 2016
- Descendant · cites it directly · 0 of its ownK220311 Cardiovascular Angiography SystemAllengers Medical Systems Limited · 2022
Show all 13 generations
- Root · 13 generations backK801623 Cavitron Ultrasonic Surg. Aspir. CusaCavitron Corp. · 1980
- 12 generations backK962952 Olympus Ultrasonic Surgical System (Usu)Olympus Optical, Co. · 1996
- 11 generations backK972114 Olympus Sonosurg SystemThe Olympus Optical Co. · 1998
- 10 generations backK981993 Olympus Integrated Endosurgery System EndoalphaThe Olympus Optical Co. · 1998
- 9 generations backK994231 Siemens Integrated Operating System (Sios)Siemens Medical Corp. · 2000
- 8 generations backK052202 Axiom Artis - Modular Angiographic SystemSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- 7 generations backK073290 Artis Zee and ZeegoSiemens Medical Solutions USA, Inc. · 2008 · Recalled
- 6 generations backK090745 Artis Zee / Zeegos with SW VC14Siemens Medical Solutions USA, Inc. · 2009 · Recalled
- 5 generations backK102005 Allura Xper or Table SeriesPhilips Medical Systems North America, Inc. · 2010 · Recalled
- 4 generations backK130638 Alluraclarity Xper FD Series X-Ray SystemPhilips Medical Systems Nederland B.V. · 2013 · Recalled
- 3 generations backK133292 Allura Xper FD; or TablePhilips Medical Systems Nederland B.V. · 2014 · Recalled
- 2 generations backK141979 Allura Xper FD Series / Allura Xper or Table SeriesPhilips Medical Systems Netherland BV · 2014 · Recalled
- 1 generation backK161563 Allura Xper FD series and Allura Xper OR Table seriesPhilips Medical Systems Nederland B.V. · 2016 · Recalled
- This deviceK162859 Allura Xper FD series and Allura Xper OR Table seriesPhilips Medical Systems Nederland B.V. · 2016
Class I recalls in this family
- K033737 Allura Xper FD205 generations back · 2003
Most influential descendants
Showing 1 of 1 · See all- K220311Cardiovascular Angiography SystemAllengers Medical Systems Limited · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K801623 | Cavitron Ultrasonic Surg. Aspir. Cusa | Cavitron Corp. | 1980 | — |
| −12 | K962952 | Olympus Ultrasonic Surgical System (Usu) | Olympus Optical, Co. | 1996 | — |
| −11 | K972114 | Olympus Sonosurg System | The Olympus Optical Co. | 1998 | — |
| −10 | K981993 | Olympus Integrated Endosurgery System Endoalpha | The Olympus Optical Co. | 1998 | — |
| −9 | K994231 | Siemens Integrated Operating System (Sios) | Siemens Medical Corp. | 2000 | — |
| −8 | K052202 | Axiom Artis - Modular Angiographic System | Siemens Medical Solutions USA, Inc. | 2006 | 29 |
| −7 | K073290 | Artis Zee and Zeego | Siemens Medical Solutions USA, Inc. | 2008 | 39 |
| −6 | K090745 | Artis Zee / Zeegos with SW VC14 | Siemens Medical Solutions USA, Inc. | 2009 | 7 |
| −5 | K102005 | Allura Xper or Table Series | Philips Medical Systems North America, Inc. | 2010 | 39 |
| −4 | K130638 | Alluraclarity Xper FD Series X-Ray System | Philips Medical Systems Nederland B.V. | 2013 | 39 |
| −3 | K133292 | Allura Xper FD; or Table | Philips Medical Systems Nederland B.V. | 2014 | 45 |
| −2 | K141979 | Allura Xper FD Series / Allura Xper or Table Series | Philips Medical Systems Netherland BV | 2014 | 81 |
| −1 | K161563 | Allura Xper FD series and Allura Xper OR Table series | Philips Medical Systems Nederland B.V. | 2016 | 45 |
| 0 (this device) | K162859 | Allura Xper FD series and Allura Xper OR Table series | Philips Medical Systems Nederland B.V. | 2016 | — |
| +1 | K220311 | Cardiovascular Angiography System | Allengers Medical Systems Limited | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 10 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 4 | 0 |
| 2001 | 1 | 0 |
| 2002 | 5 | 0 |
| 2003 | 2 | 1 |
| 2004 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
2 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new OWB device
- #1 K251602 Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6…score 18.2 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K161563 | Allura Xper FD series and Allura Xper OR Table seriesSummary page 4…series Manufacturer: Philips Medical Systems Nederland B.V. 510(k) Clearance: K161563 (July 29, 2016) Classification Name: Image-intensified fluoroscopic x-ray system… | 2016 |
| † | K130638 | Alluraclarity Xper FD Series X-Ray System | 2013 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K220311 | Cardiovascular Angiography System | 2022 | 0 |
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 29, 2026 | Class II | Z-2928-2026 | Software design | Firmware issue potentially leading to loss of geometry movements. |
| Aug 1, 2025 | Class II | Z-2503-2025 | Under Investigation by firm | Philips Azurion and Allura systems configured with a 1 Phase Uninterruptible Power Supply (UPS) have the potential of shutting down and/or not starting up, if power to the system is lost. |
| Jun 30, 2025 | Class II | Z-2189-2025 | Software design | Potential for temporary loss of imaging (X-ray) functionality due to software issue. |
| Jan 13, 2025 | Class I | Z-1152-2025 | Under Investigation by firm | Possibility of the patient falling from the table related to the mattress used on the patient table. |
| Jan 13, 2025 | Class II | Z-1081-2025 | Device Design | Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the… |
| Jan 13, 2025 | Class I | Z-1147-2025 | Under Investigation by firm | Possibility of the patient falling from the table related to the mattress used on the patient table. |
| Jan 13, 2025 | Class II | Z-1086-2025 | Device Design | Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the… |
| Jan 13, 2025 | Class II | Z-1078-2025 | Device Design | Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the… |
| Jan 13, 2025 | Class II | Z-1082-2025 | Device Design | Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the… |
| Jan 13, 2025 | Class II | Z-1076-2025 | Device Design | Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the… |
| Jan 13, 2025 | Class II | Z-1080-2025 | Device Design | Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the… |
| Jan 13, 2025 | Class II | Z-1084-2025 | Device Design | Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the… |
| Jan 13, 2025 | Class II | Z-1083-2025 | Device Design | Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the… |
| Jan 13, 2025 | Class I | Z-1148-2025 | Under Investigation by firm | Possibility of the patient falling from the table related to the mattress used on the patient table. |
| Jan 13, 2025 | Class II | Z-1079-2025 | Device Design | Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the… |
| Jan 13, 2025 | Class I | Z-1161-2025 | Under Investigation by firm | Possibility of the patient falling from the table related to the mattress used on the patient table. |
| Jan 13, 2025 | Class I | Z-1146-2025 | Under Investigation by firm | Possibility of the patient falling from the table related to the mattress used on the patient table. |
| Jan 13, 2025 | Class II | Z-1077-2025 | Device Design | Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the… |
| Jan 13, 2025 | Class II | Z-1085-2025 | Device Design | Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the… |
| Jan 13, 2025 | Class I | Z-1143-2025 | Under Investigation by firm | Possibility of the patient falling from the table related to the mattress used on the patient table. |
| Jan 13, 2025 | Class I | Z-1142-2025 | Under Investigation by firm | Possibility of the patient falling from the table related to the mattress used on the patient table. |
| Jan 13, 2025 | Class I | Z-1149-2025 | Under Investigation by firm | Possibility of the patient falling from the table related to the mattress used on the patient table. |
| Jan 13, 2025 | Class I | Z-1151-2025 | Under Investigation by firm | Possibility of the patient falling from the table related to the mattress used on the patient table. |
| Jan 13, 2025 | Class I | Z-1150-2025 | Under Investigation by firm | Possibility of the patient falling from the table related to the mattress used on the patient table. |
| Jan 13, 2025 | Class I | Z-1145-2025 | Under Investigation by firm | Possibility of the patient falling from the table related to the mattress used on the patient table. |
| Jan 13, 2025 | Class I | Z-1144-2025 | Under Investigation by firm | Possibility of the patient falling from the table related to the mattress used on the patient table. |
| May 16, 2024 | Class II | Z-1896-2024 | Under Investigation by firm | When Software upgrade 8.1.100 is installed on an Allura Xper with an AD7NT (non tilt) table, the pivot brake does not engage. This issue may cause unexpected movements of the table. |
| May 16, 2024 | Class II | Z-1895-2024 | Under Investigation by firm | When Software upgrade 8.1.100 is installed on an Allura Xper with an AD7NT (non tilt) table, the pivot brake does not engage. This issue may cause unexpected movements of the table. |
| May 16, 2024 | Class II | Z-1897-2024 | Under Investigation by firm | When Software upgrade 8.1.100 is installed on an Allura Xper with an AD7NT (non tilt) table, the pivot brake does not engage. This issue may cause unexpected movements of the table. |
| Jan 2, 2024 | Class II | Z-1156-2024 | Process design | Dual In-Line Memory Modules (DIMMs) may not perform as intended. System may stop functioning and imaging may not be possible, resulting in delay of procedure. |
| Jan 2, 2024 | Class II | Z-1144-2024 | Process design | Framegrabber card may not perform as intended. Monitor may show no viewports, or show one or more viewports may show no image, a distorted image, or a frozen image. Switching between viewports on the monitor may not be possible. Issue may… |
| Jan 2, 2024 | Class II | Z-1151-2024 | Process design | Disk Bay may not perform as intended. System may stop functioning and imaging may not be possible, resulting in delay of procedure. |
| Nov 3, 2023 | Class II | Z-0558-2024 | Device Design | Ceiling mounted L-arm contains a rotation cover that may potentially be susceptible to falling if a collision between the L-arm and other hospital equipment (i.e., an operating light) were to occur result in injury or potential sterility… |
| Aug 15, 2023 | Class II | Z-2587-2023 | Device Design | A damaged foot switch may cause instances where no or only intermittent x-ray radiation initiation is possible. |
| Jul 19, 2023 | Class II | Z-2402-2023 | Radiation Control for Health and Safety Act | A foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation |
| Jun 12, 2023 | Class II | Z-2283-2023 | Component design/selection | The bolts supporting the FlexMove Carriage may become loose and/or break, and cracks may appear in the suspension rail of the FlexMove Carriage. |
The 5 latest of 36 recalls; the web page lists all.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K033737Allura Xper FD20Philips Medical Systems North America, Inc. · 2003 · 5 generations back · ◆ in the 2003 ancestors bar of FIG. 113 Class I recalls
What does this lineage say?
- The line of descent spans 36 years and passes through 8 companies; a new generation was cleared every 1.5 years on median.
- 20 of the 54 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K220311 (Allengers Medical Systems Limited, 2022) has gone furthest, with 0 descendants of its own.
How does its category compare?
All OWB devicesOWB Interventional Fluoroscopic X-Ray System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · OWB
22in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OWB
148in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OWB
42so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OWB
14,008in 2025
MAUDE reports naming product code OWB, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 52 | 0 | 1 |
| 2008 | 4 | 135 | 1 | 0 |
| 2009 | 9 | 99 | 0 | 0 |
| 2010 | 7 | 66 | 0 | 0 |
| 2011 | 6 | 79 | 0 | 1 |
| 2012 | 6 | 37 | 0 | 1 |
| 2013 | 11 | 119 | 10 | 27 |
| 2014 | 15 | 158 | 9 | 103 |
| 2015 | 11 | 66 | 35 | 2,134 |
| 2016 | 16 | 103 | 13 | 4,074 |
| 2017 | 20 | 76 | 13 | 1,604 |
| 2018 | 23 | 54 | 6 | 1,449 |
| 2019 | 9 | 174 | 7 | 1,558 |
| 2020 | 16 | 53 | 8 | 1,581 |
| 2021 | 24 | 60 | 31 | 1,981 |
| 2022 | 21 | 90 | 24 | 2,932 |
| 2023 | 12 | 152 | 22 | 7,604 |
| 2024 | 13 | 126 | 11 | 7,942 |
| 2025 | 22 | 148 | 30 | 14,008 |
| 2026 | 15 | 221 | 42 | — |
What is it indicated for?
The Allura Xper series and the Allura Xper OR Table series (within the limits of the used OR table) are intended for use on human patients to perform: • Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. This includes, e.g., peripheral, cerebral, thoracic and abdominal angiography, as well as PTAs, stent placements, embolisations and thrombolysis. • Cardiac imaging…
Read the full statement (168 words)
The Allura Xper series and the Allura Xper OR Table series (within the limits of the used OR table) are intended for use on human patients to perform:
• Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. This includes, e.g., peripheral, cerebral, thoracic and abdominal angiography, as well as PTAs, stent placements, embolisations and thrombolysis.
• Cardiac imaging applications including diagnostics, interventional and minimally invasive procedures (such as PTCA, stent placing, atherectomies), pacemaker implantations, and electrophysiology (EP).
• Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures.
Additionally:
• The Allura Xper and Allura Xper OR Table series is compatible with a hybrid Operating Room.
• Allura Xper FD10 is compatible with specified magnetic navigation systems.
• Combined with a qualified, compatible OR table, the Allura Xper OR Table series can be used for imaging in the Hybrid OR within the applications domains Neuro, Vascular, Non Vascular and Cardiac. The OR table can also be used standalone for surgical use in the OR.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162859 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162859: Allura Xper FD series and Allura Xper OR Table series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162859
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026