# K023441: Philips Multidiagnost Eleva

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems
- Decided: Oct 30, 2002 after 15 days
- Product code: IZI (System, X-Ray, Angiographic)
- Device class: 2
- Regulation: 21 CFR 892.1600
- Recalls of this device: 15 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K961374 (1996). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961374: Philips Multidiagnost 4, Philips Medical Systems, Inc. (1996) Summary page 1.

## Most influential descendants
- K050151: Multidiagnost Eleva (2005), 0 descendants of its own

## 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
- 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-1052-2019: 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.
- Mar 26, 2018 · Class II · Z-1605-2018: 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 
- Jul 19, 2016 · Class II · Z-2307-2016: The two bolts that attach the clamping plate to the lateral shaft may break, which could cause the c-arm to move laterally forward, slide out of its bearings, and sag
- Jul 19, 2016 · Class II · Z-2305-2016: The two bolts that attach the clamping plate to the lateral shaft may break, which could cause the c-arm to move laterally forward, slide out of its bearings, and sag
- Oct 14, 2013 · Class II · Z-1044-2015: 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
- May 21, 2012 · Class II · Z-1829-2012: MultiDiagnost Eleva X--Ray system may have damage to System Cables from repeated movement
- Feb 24, 2012 · Not classified · Z-1196-2012: Displayed skin dose rate is calculated using an incorrect point of reference, resulting in too low displayed values.
- Feb 24, 2012 · Not classified · Z-1197-2012: Displayed skin dose rate is calculated using an incorrect point of reference, resulting in too low displayed values.
- Jan 9, 2012 · Not classified · Z-0985-2012: Incorrect Skin Dose calculation. AKR (Air Kerma Rate) displayed and stored in patient records is too low
- Oct 7, 2010 · Not classified · Z-1656-2011: A wire in the connector of the Generator Grid Switch Supervisor box might short-circuit between 12V power and ground, and it will cause a System breakdown.
- Mar 6, 2009 · Not classified · Z-0917-2011: Images from two different patients may be combined in one patient folder in the Digital Image (DI) or may be combined as one (printed) image. It is possible that an image of a previous patient registe
- Jul 23, 2007 · Not classified · Z-0912-2007: Units do not comply with the requirement to provide automatic beam limitation within +/- 3 degrees of horizontal, vertical, and perpendicular to the plane of the image receptor during radiographic pro

## Indications for use
The MultiDiagnost Eleva is indicated for use in Radiographic/Fluoroscopic, Angiographic, and Interventional diagnostic imaging examinations.

Source page: https://510kreport.com/device/K023441
Methodology: https://510kreport.com/methodology