GE Quasar Nuclear Medicine System

• • Ongoing Z-2097-2025 FDA Class II ·initiated 20 Jun 2025

  Unintended radial detector motion may occur during patient setup or during patient scan if system does not have correct version of gantry software installed. Unintended detector motion may result in life-threatening injury.

• 4 recalls, same reason

  • Ongoing Z-0888-2025 FDA Class II ·initiated 18 Dec 2024
  • Ongoing Z-0897-2025 FDA Class II ·initiated 18 Dec 2024
  • Ongoing Z-0899-2025 FDA Class II ·initiated 18 Dec 2024
  • Ongoing Z-0898-2025 FDA Class II ·initiated 18 Dec 2024

  GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could have been transported or relocated without proper detector support, which can result in excessive load being applied to the detector mounting mechanisms. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.

• 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-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.

• 3 recalls, same reason

  • Terminated Z-1200-2014 FDA Class II ·initiated 7 Feb 2014
  • Terminated Z-1199-2014 FDA Class II ·initiated 7 Feb 2014
  • Terminated Z-1198-2014 FDA Class II ·initiated 7 Feb 2014

  Potential safety issue related to unintended radial detector motion, which may occur during patient setup or at the end of a patient scan. This failure mode has been observed on a single system, in which the detector moved to the home position and then slowly starting drifting inward toward the patient. This generated both a visual and audio alert condition on both the console and the gantry. N

• • 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.

• 2 recalls, same reason

  • Terminated Z-1095-2009 FDA Unclassified (pre-2012) ·initiated 8 Sep 2008
  • Terminated Z-1094-2009 FDA Unclassified (pre-2012) ·initiated 8 Sep 2008

  There is a possibility for misregistration when brain scans are performed with Infinia with the Hawkeye option. This misregistration could present the potential for misdiagnosis when the patient headrest sags under the weight of a head.

• 3 recalls, same reason

  • Terminated Z-1120-2009 FDA Unclassified (pre-2012) ·initiated 2 Jun 2008
  • Terminated Z-1121-2009 FDA Unclassified (pre-2012) ·initiated 2 Jun 2008
  • Terminated Z-1119-2009 FDA Unclassified (pre-2012) ·initiated 2 Jun 2008

  The metal pin in the adjustable head holder, which is used to acquire Brain SPECT data on Infinia systems (Infinia, Infinia Hawkeye, and Infinia Hawkeye 4), creates an artifact on the patient's cerebellum, which may lead to the potential for misdiagnosis.

• 3 recalls, same reason

  • Terminated Z-1002-2009 FDA Unclassified (pre-2012) ·initiated 2 Jun 2008
  • Terminated Z-1001-2009 FDA Unclassified (pre-2012) ·initiated 2 Jun 2008
  • Terminated Z-1003-2009 FDA Unclassified (pre-2012) ·initiated 2 Jun 2008

  GE Healthcare has recently became aware of excessive pressure applied by the collimator pressure sensitive cover of Infinia (Infinia, Infinia Hawkeye, Infinia Hawkeye 4) that may impact patient safety. It was reported at a customer site that the pressure used to activate the Pressure Sensitive Device (PSD) should be lowered and that the body contouring software requires correction to prevent po

510(k) Number

K022960 ↗

FDA Product Code

KPS

Device Class

Class II

Regulation

21 CFR Part 892.1200

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Qps/Bpgs/Moco Processing Applications for Entegra Workstation

  Class II

  FDA 510(k) K003264 Active Cleared 21 Dec 2000

• Ventri 1.1 Open recall

  Class II

  FDA 510(k) K080124 Active Cleared 31 Jan 2008

• Xeleris 3 Processing and Review Workstation

  Class II

  FDA 510(k) K093982 Active Cleared 8 Jan 2010

• GE Photon Energy Recovery (per) Option

  Class II

  FDA 510(k) K023932 Active Cleared 11 Dec 2002

• Discovery Model Nm/CT 670 Open recall

  Class II

  FDA 510(k) K093514 Active Cleared 10 Dec 2009

• Myolight

  Class II

  FDA 510(k) K033874 Active Cleared 30 Dec 2003

See all devices from Ge Medical Systems F.I. Haifa →