Griffin Spect/CT Imaging System

• 2 recalls, same reason

  • Terminated Z-0513-2018 FDA Class II ·initiated 15 Dec 2017
  • Terminated Z-0514-2018 FDA Class II ·initiated 15 Dec 2017

  During collimator exchange, the alignment of the collimator cart and detectors may cause a collimator exchange fail, and a collimator may drop to the floor beside the collimator cart. The collimator may be partially supported by the cart (e.g. leaning against the cart), or it may fall/slide all the way to the floor.

• 2 recalls, same reason

  • Terminated Z-1779-2015 FDA Class II ·initiated 6 Mar 2015
  • Terminated Z-1778-2015 FDA Class II ·initiated 6 Mar 2015

  The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overheating and/or emission of fumes.

• 4 recalls, same reason

  • Terminated Z-0256-2012 FDA Unclassified (pre-2012) ·initiated 27 Sep 2011
  • Terminated Z-0258-2012 FDA Unclassified (pre-2012) ·initiated 27 Sep 2011
  • Terminated Z-0257-2012 FDA Unclassified (pre-2012) ·initiated 27 Sep 2011
  • Terminated Z-0255-2012 FDA Unclassified (pre-2012) ·initiated 27 Sep 2011

  A mechanical malfunction of the button on the hand controller on the Philips Precedence and SKYLight SPECT systems may get stuck and cause unintended motion of a detector.

• 2 recalls, same reason

  • Terminated Z-1550-2011 FDA Unclassified (pre-2012) ·initiated 28 Dec 2010 ·on shared 510(k) K041218
  • Terminated Z-1549-2011 FDA Unclassified (pre-2012) ·initiated 28 Dec 2010 ·on shared 510(k) K041218

  Philips Healthcare Nuclear Medicine determined that the detector arm assembly could be compromised.

• • Terminated Z-0676-2008 FDA Unclassified (pre-2012) ·initiated 28 Sep 2007

  Incorrect Measurement: The firm discovered a software defect in Cardiac and Pulmonary Viewer software application options used in the Precedence CT Sub-System. The defect causes incorrect measurements in derived images which are zoomed and saved in a batch file.

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

510(k) Number

K041218 ↗

FDA Product Code

KPS

Device Class

Class II

Regulation

21 CFR Part 892.1200

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Jetstream Workspace

  Class II

  FDA 510(k) K042880 Active Cleared 3 Nov 2004

• Adac Model Dps-3300M Digital Processing System

  Class II

  FDA 510(k) K844298 Active Cleared 1 Mar 1985

• DPS-33000 Nuclear Medicine Imaging Computer

  Class II

  FDA 510(k) K844784 Active Cleared 1 Feb 1985

• Ensphere Tempo Jetstream Workspace Cardiology Module

  Class II

  FDA 510(k) K040142 Active Cleared 6 Feb 2004

• Skylight Imaging System

  Class II

  FDA 510(k) K000908 Active Cleared 5 Apr 2000

• Adac Viewpoint (Additional Software)

  Class II

  FDA 510(k) K884349 Active Cleared 22 Dec 1988

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