510(k) · Cleared
Recalled · Class I · 2025Allura Xper FD20
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems North America, Inc. · OWB Interventional Fluoroscopic X-Ray System
Cleared on Dec 9, 2003 as substantially equivalent to K002016 (Philips Medical Systems North America, Inc., 2000) after an 11-day review. Its family tree reaches back 1 generation to 2000. 6 of the 28 devices in its family, counting itself, have a Class I recall. 26 later devices descend from it. It has been recalled 54 times, including 13 Class I recalls.
- Decided
- Dec 9, 2003
- Review
- 11 days
- Class
- Class II
- Product code
- OWB
- Recalls
- 54 (13 Class I)
- Predicates
- 1
Its longest line of descent runs back 1 generation to K002016 (2000). 26 later devices descend from it, 5 citing it directly. 6 of the 28 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK002016 Philips Integris AlluraPhilips Medical Systems North America, Inc. · 2000 · Recalled
- This deviceK033737 Allura Xper FD20Philips Medical Systems North America, Inc. · 2003
- Descendant · cites it directly · 24 of its ownK102005 Allura Xper or Table SeriesPhilips Medical Systems North America, Inc. · 2010 · Recalled
- Descendant · cites it directly · 18 of its ownK130638 Alluraclarity Xper FD Series X-Ray SystemPhilips Medical Systems Nederland B.V. · 2013 · Recalled
- Descendant · 2 generations on · 15 of its ownK133292 Allura Xper FD; or TablePhilips Medical Systems Nederland B.V. · 2014 · Recalled
- Descendant · 3 generations on · 13 of its ownK141979 Allura Xper FD Series / Allura Xper or Table SeriesPhilips Medical Systems Netherland BV · 2014 · Recalled
- Descendant · 4 generations on · 8 of its ownK162148 Allura Xper R9Philips Medical Systems Nethrlands BV · 2016 · Recalled
Showing 5 of 26 descendants. See all descendants
Descendants cleared per year
2010high 5 (2016) · low 0 (2011)2026
Class I recalls in this family
Most influential descendants
Showing 5 of 26 · See all- K102005Allura Xper or Table SeriesPhilips Medical Systems North America, Inc. · 2010 · cites it directly24descendants
- K130638Alluraclarity Xper FD Series X-Ray SystemPhilips Medical Systems Nederland B.V. · 2013 · cites it directly18descendants
- K133292Allura Xper FD; or TablePhilips Medical Systems Nederland B.V. · 2014 · 2 generations on15descendants
- K141979Allura Xper FD Series / Allura Xper or Table SeriesPhilips Medical Systems Netherland BV · 2014 · 3 generations on13descendants
- K162148Allura Xper R9Philips Medical Systems Nethrlands BV · 2016 · 4 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K002016 | Philips Integris Allura | Philips Medical Systems North America, Inc. | 2000 | 13 |
| 0 (this device) | K033737 | Allura Xper FD20 | Philips Medical Systems North America, Inc. | 2003 | — |
| +1 | K102005 | Allura Xper or Table Series | Philips Medical Systems North America, Inc. | 2010 | 39 |
| +1 | K130638 | Alluraclarity Xper FD Series X-Ray System | Philips Medical Systems Nederland B.V. | 2013 | 39 |
| +2 | K133292 | Allura Xper FD; or Table | Philips Medical Systems Nederland B.V. | 2014 | 45 |
| +3 | K141979 | Allura Xper FD Series / Allura Xper or Table Series | Philips Medical Systems Netherland BV | 2014 | 81 |
| +4 | K162148 | Allura Xper R9 | Philips Medical Systems Nethrlands BV | 2016 | 3 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2013 | 4 | 1 |
| 2014 | 4 | 0 |
| 2016 | 5 | 1 |
| 2017 | 2 | 2 |
| 2018 | 2 | 0 |
| 2020 | 1 | 1 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 2 | 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.
6 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 18.3 · 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 |
|---|---|---|---|
| * | K002016 | Philips Integris AlluraSummary page 1…equivalent to the Integris Allura, both manufactured by Philips Medical Systems. The Philips Integris Allura received a 510(k) substantially equivalent determination in K002016 on September 6, 2000. Device description: The Allura Xper FD20 is a stationary fluoroscopic angiographic X-ray system for vascul… | 2000 |
What descends from it? (26)
See all 265 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (6 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 13, 2025 | Class I | Z-1160-2025 | 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. |
| Jan 13, 2025 | Class I | Z-1159-2025 | 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-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 I | Z-1154-2025 | 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-1158-2025 | 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-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 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-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-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-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 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 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… |
| Feb 19, 2019 | Class II | Z-1141-2019 | Component design/selection | Additional units have been identified for previous recall Z-1280-2016 (RES 69339): If a Footswitch is frequently used on a non-flat surface or in the pedestal, the footswitch pedals may get bent. This might cause an intermittent or… |
| Feb 19, 2019 | Class II | Z-1140-2019 | Component design/selection | Additional units have been identified for previous recall Z-1280-2016 (RES 69339): If a Footswitch is frequently used on a non-flat surface or in the pedestal, the footswitch pedals may get bent. This might cause an intermittent or… |
| Jul 16, 2018 | Class II | Z-3222-2018 | Device Design | There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft causing the monitor to fall from the ground. When a Monitor Ceiling Suspension detaches from the… |
| Jul 16, 2018 | Class II | Z-3224-2018 | Device Design | There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft causing the monitor to fall from the ground. When a Monitor Ceiling Suspension detaches from the… |
| Jul 16, 2018 | Class II | Z-3221-2018 | Device Design | There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft causing the monitor to fall from the ground. When a Monitor Ceiling Suspension detaches from the… |
| Jul 16, 2018 | Class II | Z-3223-2018 | Device Design | There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft causing the monitor to fall from the ground. When a Monitor Ceiling Suspension detaches from the… |
| Mar 22, 2017 | Class II | Z-1822-2017 | Under Investigation by firm | Due to a leak in the detector cooling system, cooling liquid may leak outside the drip tray of the chiller. If this occurs the liquid may drip onto electrical components in the R cabinet located in the technical room, which could lead to… |
| Dec 9, 2016 | Class II | Z-1061-2017 | Device Design | System may lock up. |
| Dec 9, 2016 | Class II | Z-1062-2017 | Device Design | System may lock up. |
| Dec 1, 2016 | Class II | Z-0922-2017 | Process control | Due to a production error, screws were not tightened to specified torque. These screws may come loose from the C-arm shaft causing the C-arm to rotate uncontrolled. |
| Nov 3, 2015 | Class II | Z-0764-2016 | Device Design | Normally, movement of the C-arc is initially stopped by the motor (holding torque) then by the electromagnetic brake, leading to a full stop of the C-arc. Because of improper adjustment and tolerances, when the C-arc is initially stopped… |
| Jul 6, 2015 | Class II | Z-0810-2016 | Process control | The actuator assembly became detached and the monitor carriage with a flexvision monitor dropped to its lowest position. |
| Feb 3, 2015 | Class II | Z-0346-2016 | Process control | Monitor Ceiling Suspension system may fall |
| Feb 3, 2015 | Class II | Z-0349-2016 | Process control | Monitor Ceiling Suspension system may fall |
| Feb 3, 2015 | Class II | Z-0354-2016 | Process control | Monitor Ceiling Suspension system may fall |
| Feb 3, 2015 | Class II | Z-0353-2016 | Process control | Monitor Ceiling Suspension system may fall |
| Feb 3, 2015 | Class II | Z-0348-2016 | Process control | Monitor Ceiling Suspension system may fall |
| Feb 3, 2015 | Class II | Z-0350-2016 | Process control | Monitor Ceiling Suspension system may fall |
| Feb 3, 2015 | Class II | Z-0351-2016 | Process control | Monitor Ceiling Suspension system may fall |
| Feb 3, 2015 | Class II | Z-0352-2016 | Process control | Monitor Ceiling Suspension system may fall |
| Feb 3, 2015 | Class II | Z-0347-2016 | Process control | Monitor Ceiling Suspension system may fall |
| Sep 24, 2014 | Class II | Z-1280-2016 | Device Design | Loss of key image functionality due to a bent pedal of the Footswitch. |
| Jul 8, 2014 | Class II | Z-0181-2015 | Software design | Faulty Automatic Motion Controller (AMC), a problem in the Power On Self Test (POST) error handling was detected, can result in a hazardous movement of the C-arc. system. |
| Jul 8, 2014 | Class II | Z-0182-2015 | Software design | Faulty Automatic Motion Controller (AMC), a problem in the Power On Self Test (POST) error handling was detected, can result in a hazardous movement of the C-arc. system. |
| Apr 2, 2012 | Not classified | Z-1462-2012 | Process control | The monitor Ceiling suspension may fail, which may cause the monitor to drop. |
| Jul 8, 2011 | Not classified | Z-2976-2011 | Software design | System freezes from 20 seconds up to one minute. No fluoroscopy exposure and no geometry movements during this time period. |
| Nov 4, 2010 | Not classified | Z-1368-2011 | Pending | Adjustment of the micro-switches in the footswitch used on the Philips cardiovascular X-ray systems was not implemented. If it is programmed for exposure, it is possible that after pressing the pedal on the footswitch it does not release… |
| Feb 4, 2010 | Not classified | Z-2448-2010 | Software design | A lock-up might occur inside the Velara Generator due to intermittent shorts inside the system. The problem could only resolved by a warm or cold system restart. In exceptional cases the power converters of the KVmA unit in the generator… |
| Feb 4, 2010 | Not classified | Z-2449-2010 | Software design | A lock-up might occur inside the Velara Generator due to intermittent shorts inside the system. The problem can only resolved by a warm or cold system restart. In exceptional cases the power converters of the KVmA unit in the generator… |
| Dec 10, 2008 | Not classified | Z-0348-2009 | Radiation Control for Health and Safety Act | Tube failure occurs involving fluoroscopy of large patients and a partial failure of the grid switch. |
| Dec 10, 2008 | Not classified | Z-0349-2009 | Radiation Control for Health and Safety Act | Tube failure occurs involving fluoroscopy of large patients and a partial failure of the grid switch. |
| Oct 23, 2008 | Not classified | Z-2475-2010 | Other | A high voltage reliability issue resulting in the loss of the x-ray generation and this can cause an intermittent stop of fluoro acquisition and exposure during an examination without warning and hence no image on the display. |
| Oct 23, 2008 | Not classified | Z-2476-2010 | Other | A high voltage reliability issue resulting in the loss of the x-ray generation and this can cause an intermittent stop of fluoro acquisition and exposure during an examination without warning and hence no image on the display. |
| Sep 24, 2007 | Not classified | Z-0329-2008 | Device Design | Inaccurate anatomical measurements when using the optional SmartMask feature |
| Sep 24, 2007 | Not classified | Z-0330-2008 | Device Design | Inaccurate anatomical measurements when using the optional SmartMask feature |
The 5 latest of 50 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.
- K130842Allura Xper FD or Table Series; Allura Xper FD10 Series; Allura Xper FD20 Series; Allura Xper FD Biplane…Philips Medical Systems Nederland B.V. · 2013 · Cites it directly · ◆ in the 2013 descendants bar of FIG. 111 Class I recalls
- K162859Allura Xper FD series and Allura Xper OR Table seriesPhilips Medical Systems Nederland B.V. · 2016 · 5 generations on · ◆ in the 2016 descendants bar of FIG. 112 Class I recalls
- K163715Allura Xper R9Philips Medical Systems Nederland B.V. · 2017 · 5 generations on · ◆ in the 2017 descendants bar of FIG. 17 Class I recalls
- K172822Azurion series R1.2Philips Medical Systems Nederland B.V. · 2017 · 6 generations on · ◆ in the 2017 descendants bar of FIG. 19 Class I recalls
- K200917Azurion R2.1Philips Medical Systems Nederland B.V. · 2020 · 7 generations on · ◆ in the 2020 descendants bar of FIG. 18 Class I recalls
What does this lineage say?
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.
FDA decisions per year · OWB
22in 2025
2007high 24 (2021) · low 3 (2007)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · OWB
148in 2025
2007high 221 (2026) · low 37 (2012)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OWB
42so far in 2026, the most since 2007
2007high 42 (2026) · low 0 (2007)2026
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OWB
14,008in 2025
2007high 14,008 (2025) · low 0 (2008)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 FD20 is intended for:
o Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. This includes, e.g., peripheral, cerebral, thoracic and abdominal angiography, as well as PTCAs, stent placements, embolisations and thrombolysis.
o Cardiac imaging applications including diagnostics, interventional procedures (such as PTCA, stent placing, atherectomiss), pacemaker implantations, and electrophysiology (EP).
» Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K033737 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033737: Allura Xper FD20.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033737
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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