Hawkeye Option for Dual-Head Variable Angle Gamma Camera

• • Terminated Z-0187-2015 FDA Class II ·initiated 14 Oct 2014

  GE is updating the Preventative Maintenance procedure and schedule, and added an additional Preventative Maintenance check for loose fasteners on the Nuclear Medicaine systems. This check is being added to prevent a portion of the system falling onto the patient during a scan due to fasteners being loose that secure the camera to the gantry.

• 5 recalls, same reason

  • Terminated Z-0186-2015 FDA Class II ·initiated 14 Oct 2014
  • Terminated Z-0184-2015 FDA Class II ·initiated 14 Oct 2014
  • Terminated Z-0189-2015 FDA Class II ·initiated 14 Oct 2014
  • Terminated Z-0188-2015 FDA Class II ·initiated 14 Oct 2014
  • Terminated Z-0185-2015 FDA Class II ·initiated 14 Oct 2014

  GE is issuing this recall due to a potential safety issue related to a portion of the system falling onto the patient during a scan due to fasteners being loose that secured the camera to the gantry. GE is updating the Preventative Maintenance procedure and schedule, and added an additional Preventative Maintenance check for loose fasteners on the Nuclear Medicaine systems.

• • Terminated Z-1787-2013 FDA Class I ·initiated 13 Jun 2013

  GE became aware of an incident at a VA Medical Center facility in the US in which a patient died due to injuries sustained while being scanned on an Infinia Hawkeye 4 Nuclear Medicine System.

• • Terminated Z-1078-2013 FDA Class II ·initiated 6 Mar 2012

  Accelerated fatigue of the lateral axis motion subsystem of the Infinia Computed Emission Tomography System could result in mechanical failure causing the detector to slide; may impact patient and operators.

510(k) Number

K991841 ↗

FDA Product Code

KPS

Device Class

Class II

Regulation

21 CFR Part 892.1200

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K023932 Active Cleared 11 Dec 2002

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  Class II

  FDA 510(k) K022960 Active Cleared 19 Sep 2002

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  Class II

  FDA 510(k) K093514 Active Cleared 10 Dec 2009

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