Skylight Imaging System

• • Terminated Z-1219-2012 FDA Not yet classified ·initiated 23 Feb 2012

  Incorrect Standardized Uptake Value ("SUV") values are displayed in two instances: 1. After loading PET data (with a Slope value different than 1) into the Quick Review (QR) application from a remote device; and 2. During the loading the above mentioned type of PET data into the CT viewer application from a remote device.

• • Terminated Z-0607-2012 FDA Unclassified (pre-2012) ·initiated 8 Dec 2011

  During preventative maintenance, a crack was discovered in the lower portion of the old style, non-common arm for the detector assembly, which could result in the detector dropping in an uncontrolled manner.

• 8 recalls, same reason

  • Terminated Z-0247-2012 FDA Unclassified (pre-2012) ·initiated 27 Sep 2011
  • Terminated Z-0251-2012 FDA Unclassified (pre-2012) ·initiated 27 Sep 2011
  • Terminated Z-0249-2012 FDA Unclassified (pre-2012) ·initiated 27 Sep 2011
  • Terminated Z-0254-2012 FDA Unclassified (pre-2012) ·initiated 27 Sep 2011
  • Terminated Z-0252-2012 FDA Unclassified (pre-2012) ·initiated 27 Sep 2011
  • Terminated Z-0250-2012 FDA Unclassified (pre-2012) ·initiated 27 Sep 2011
  • Terminated Z-0253-2012 FDA Unclassified (pre-2012) ·initiated 27 Sep 2011
  • Terminated Z-0248-2012 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-1552-2011 FDA Unclassified (pre-2012) ·initiated 28 Dec 2010
  • Terminated Z-1551-2011 FDA Unclassified (pre-2012) ·initiated 28 Dec 2010

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

• • Terminated Z-0398-2011 FDA Unclassified (pre-2012) ·initiated 15 Oct 2010

  Detector arm assembly may slide to hardware limit, potentially causing impact.

510(k) Number

K000908 ↗

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

• Adac Viewpoint (Additional Software)

  Class II

  FDA 510(k) K884349 Active Cleared 22 Dec 1988

• Vantage 2.1 Exspect

  Class II

  FDA 510(k) K971878 Active Cleared 8 Aug 1997

See all devices from Adac Laboratories →