Multidiagnost Eleva

• • Ongoing Z-2411-2026 FDA Class II ·initiated 18 May 2026 ·on shared 510(k) K050151

  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 injection

• • Ongoing Z-3168-2024 FDA Class II ·initiated 22 Aug 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.

• • Ongoing Z-2587-2023 FDA Class II ·initiated 15 Aug 2023 ·on shared 510(k) K050151

  A damaged foot switch may cause instances where no or only intermittent x-ray radiation initiation is possible.

• • Ongoing Z-2404-2023 FDA Class II ·initiated 19 Jul 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

• • Terminated Z-1489-2020 FDA Class II ·initiated 30 Dec 2019 ·on shared 510(k) K050151

  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.

• • Terminated Z-1055-2019 FDA Class II ·initiated 28 Feb 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.

• 2 recalls, same reason

  • Terminated Z-1140-2019 FDA Class II ·initiated 19 Feb 2019 ·on shared 510(k) K050151
  • Terminated Z-1141-2019 FDA Class II ·initiated 19 Feb 2019 ·on shared 510(k) K050151

  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 continuous inability of making live fluoroscopy images or exposures.

• 5 recalls, same reason

  • Terminated Z-1609-2018 FDA Class II ·initiated 26 Mar 2018
  • Terminated Z-1606-2018 FDA Class II ·initiated 26 Mar 2018
  • Terminated Z-1607-2018 FDA Class II ·initiated 26 Mar 2018
  • Terminated Z-1608-2018 FDA Class II ·initiated 26 Mar 2018
  • Terminated Z-1603-2018 FDA Class II ·initiated 26 Mar 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 be stopped by the user.

• 2 recalls, same reason

  • Terminated Z-1280-2016 FDA Class II ·initiated 24 Sep 2014 ·on shared 510(k) K050151
  • Terminated Z-1279-2016 FDA Class II ·initiated 24 Sep 2014

  Loss of key image functionality due to a bent pedal of the Footswitch.

• • Terminated Z-1045-2015 FDA Class II ·initiated 14 Oct 2013 ·on shared 510(k) K050151

  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 expected.

• • Terminated Z-2156-2012 FDA Class II ·initiated 11 Jul 2012

  When doing a 3 Dimensional Rotational Angiography (3DRA) the 3D reconstruction does not always start, even when all images have been acquired.

• • Terminated Z-1829-2012 FDA Class II ·initiated 21 May 2012 ·on shared 510(k) K050151

  MultiDiagnost Eleva X--Ray system may have damage to System Cables from repeated movement

• • Terminated Z-0936-2012 FDA Not yet classified ·initiated 9 Jan 2012 ·on shared 510(k) K050151

  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 the patient is not affected.

• • Terminated Z-0623-2009 FDA Unclassified (pre-2012) ·initiated 30 Dec 2008

  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.

• • Terminated Z-1137-2008 FDA Unclassified (pre-2012) ·initiated 29 Nov 2007 ·on shared 510(k) K050151

  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 performed and new exposures are not able to be acquired until the housekeeping operations are complete which may take several minutes. The loss of system availability could occur during an interventional

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K050151 ↗

FDA Product Code

KPR

Device Class

Class II

Regulation

21 CFR Part 892.1680

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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