# K050151: Multidiagnost Eleva

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems North America, Inc.
- Decided: Feb 9, 2005 after 16 days
- Product code: KPR (System, X-Ray, Stationary)
- Device class: 2
- Regulation: 21 CFR 892.1680
- Recalls of this device: 21 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K961374 (1996). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023441: Philips Multidiagnost Eleva, Philips Medical Systems (2002) Summary page 1.

## Recalls of this device
- May 18, 2026 · Class II · Z-2411-2026: Philips Allura Xper and MultiDiagnost-Eleva systems Hand switch button not fully releasing potentially leading to loss of imaging functionality or unintended radiation exposure and additional contrast
- Aug 22, 2024 · Class II · Z-3168-2024: Potential Detachment of the Cable Hose Carrier (due to broken plastic and/or bolts) which May Result in Parts Falling and/or Part of the Cable Hose Dropping, and result in injury.
- Aug 15, 2023 · Class II · Z-2587-2023: A damaged foot switch may cause instances where no or only intermittent x-ray radiation initiation is possible.
- Jul 19, 2023 · Class II · Z-2404-2023: A foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation
- Dec 30, 2019 · Class II · Z-1489-2020: A capacitor inside the converter of the Velara X-ray generator may fail after a large number of surges in a short period of time. When this occurs, no image acquisition is possible.
- Feb 28, 2019 · Class II · Z-1055-2019: The locking plate may be missing from the system, which may result in unexpected stand/table tilt movement that cannot be stopped by the user.
- Feb 19, 2019 · Class II · Z-1140-2019: 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
- Feb 19, 2019 · Class II · Z-1141-2019: 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
- Mar 26, 2018 · Class II · Z-1606-2018: The fixation of the upper and lower tilt actuator, of the MD-Eleva system might break off and the table will start to rotate from 0 to + 90 I- 90 degree with high speed. This rotating movement cannot 
- Mar 26, 2018 · Class II · Z-1608-2018: The fixation of the upper and lower tilt actuator, of the MD-Eleva system might break off and the table will start to rotate from 0 to + 90 I- 90 degree with high speed. This rotating movement cannot 
- Mar 26, 2018 · Class II · Z-1607-2018: The fixation of the upper and lower tilt actuator, of the MD-Eleva system might break off and the table will start to rotate from 0 to + 90 I- 90 degree with high speed. This rotating movement cannot 
- Mar 26, 2018 · Class II · Z-1609-2018: The fixation of the upper and lower tilt actuator, of the MD-Eleva system might break off and the table will start to rotate from 0 to + 90 I- 90 degree with high speed. This rotating movement cannot 
- Mar 26, 2018 · Class II · Z-1603-2018: The fixation of the upper and lower tilt actuator, of the MD-Eleva system might break off and the table will start to rotate from 0 to + 90 I- 90 degree with high speed. This rotating movement cannot 
- Sep 24, 2014 · Class II · Z-1279-2016: Loss of key image functionality due to a bent pedal of the Footswitch.
- Sep 24, 2014 · Class II · Z-1280-2016: Loss of key image functionality due to a bent pedal of the Footswitch.
- Oct 14, 2013 · Class II · Z-1045-2015: The possibility of the Reference Air Kerma Rate for low dose mode will not be reduced to 50% of the value for the normal mode, but will be approximately 70-80%, leading to a higher patient dose than e
- Jul 11, 2012 · Class II · Z-2156-2012: When doing a 3 Dimensional Rotational Angiography (3DRA) the 3D reconstruction does not always start, even when all images have been acquired.
- May 21, 2012 · Class II · Z-1829-2012: MultiDiagnost Eleva X--Ray system may have damage to System Cables from repeated movement
- Jan 9, 2012 · Not classified · Z-0936-2012: The skin dose and skin dose rate values are calculated using an incorrect point of reference. Therefore, the AKR as displayed and stored in patient records is too low, although the dose as received by
- Dec 30, 2008 · Not classified · Z-0623-2009: System fails to meet requirements when it is used at kV levels greater than 115 kV at certain frame rates and in certain acquisition modes, as grid switch leakage may occur.
- Nov 29, 2007 · Not classified · Z-1137-2008: Delay in Imaging: MultiDiagnost Eleva with Flat Detector x-ray system cannot perform fluoroscopy procedures while certain image file housekeeping operations are performed. Fluoroscopy cannot be perfor

## Indications for use
As a multi-functional/universal system, general R/F, Fluoroscopy, Radiography and Angiography can be performed along with more specialized interventional applications. This includes the following general areas: * Digestive System: Swallowing studies, Oesophagus, Stomach, Small intestine, Colon, Defeacography, ERCP, T-tube cholangiogram, Liver biopsies, Transjugular Intrahepatic Portosystemic Shunts (TIPS). * Skeletal System: Bone studies. * Urinary System: IVP, Cystograms, Percutaneous Nephrolithotomy, Nephrostomy tube placement. * Reproductive System: Hysterosalpingograms, Vena spermatica, Cavemography. * Respiratory System: Thorax, Bronchoscopy, Pulmonary biopsies. * Circulatory System: Venography, Arteriography, Thrombolytic Therapy, Embolizations, Embolectomy, TVC filter placement, Dilatations, Stent placement. * Various: Arthrograms, Myelograms, Facet joint injections, Discography, Sialography.

Source page: https://510kreport.com/device/K050151
Methodology: https://510kreport.com/methodology