Philips Integris H5000

• • Terminated Z-1491-2020 FDA Class II ·initiated 30 Dec 2019

  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.

• 6 recalls, same reason

  • Terminated Z-0718-2016 FDA Class II ·initiated 3 Nov 2015
  • Terminated Z-0719-2016 FDA Class II ·initiated 3 Nov 2015
  • Terminated Z-0730-2016 FDA Class II ·initiated 3 Nov 2015
  • Terminated Z-0720-2016 FDA Class II ·initiated 3 Nov 2015
  • Terminated Z-0717-2016 FDA Class II ·initiated 3 Nov 2015
  • Terminated Z-0721-2016 FDA Class II ·initiated 3 Nov 2015

  The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images.

• 9 recalls, same reason

  • Terminated Z-0354-2016 FDA Class II ·initiated 3 Feb 2015 ·on shared 510(k) K971365
  • Terminated Z-0353-2016 FDA Class II ·initiated 3 Feb 2015 ·on shared 510(k) K971365
  • Terminated Z-0351-2016 FDA Class II ·initiated 3 Feb 2015 ·on shared 510(k) K971365
  • Terminated Z-0348-2016 FDA Class II ·initiated 3 Feb 2015 ·on shared 510(k) K971365
  • Terminated Z-0350-2016 FDA Class II ·initiated 3 Feb 2015 ·on shared 510(k) K971365
  • Terminated Z-0347-2016 FDA Class II ·initiated 3 Feb 2015 ·on shared 510(k) K971365
  • Terminated Z-0349-2016 FDA Class II ·initiated 3 Feb 2015 ·on shared 510(k) K971365
  • Terminated Z-0346-2016 FDA Class II ·initiated 3 Feb 2015 ·on shared 510(k) K971365
  • Terminated Z-0352-2016 FDA Class II ·initiated 3 Feb 2015 ·on shared 510(k) K971365

  Monitor Ceiling Suspension system may fall

• • Terminated Z-0099-04 FDA Unclassified (pre-2012) ·initiated 10 Oct 2003 ·on shared 510(k) K971365

  The cable carrier and cables may fall after repeat collisions with OR lamps, radiation shields or other supported accessories.

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

510(k) Number

K971365 ↗

FDA Product Code

IZI

Device Class

Class II

Regulation

21 CFR Part 892.1600

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Tomoscan Stereotaxis Simulation Software

  Class II

  FDA 510(k) K900660 Active Cleared 13 Mar 1990

• Integris 3D-Ra, Release 4.2

  Class II

  FDA 510(k) K040254 Active Cleared 19 Feb 2004

• Ep Navigator R3

  Class II

  FDA 510(k) K101311 Active Cleared 30 Sep 2010

• Orthoralix Sd/Orthoralix Sd Ceph

  Class II

  FDA 510(k) K890351 Active Cleared 15 Jun 1989

• Doppler Option for Platinum

  Class II

  FDA 510(k) K900002 Active Cleared 2 Apr 1990

• Philips Bucky Diagnost Family

  Class II

  FDA 510(k) K945278 Active Cleared 14 Dec 1994

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