The Recall Desk
CriticalFDA (Devices)·Z-1787-2013·Announced 2013-07-31

GE Healthcare Recalls Infinia Hawkeye 4 Gamma Cameras Due to Patient Death

GE Healthcare is recalling Infinia Hawkeye 4 Nuclear Medicine Systems after a patient died from injuries sustained during a scan at a US VA Medical Center.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The source text explicitly states that a patient died due to injuries sustained while being scanned on the device. Per the rubric, reported deaths result in a score of 5 (Critical).

Plain-English summary

GE Healthcare, LLC is recalling the Infinia Hawkeye 4 Option for Dual-Head Variable Angle Gamma Camera, which includes GE Quasar Nuclear Medicine Systems and Infinia devices. The recall is being conducted by the U.S. Food and Drug Administration (FDA) following a reported incident at a VA Medical Center facility in the United States.

The recall was initiated because a patient died due to injuries sustained while being scanned on an Infinia Hawkeye 4 Nuclear Medicine System. The affected products are intended for general Nuclear Medicine imaging procedures to detect radioisotope tracer uptake in the patient body.

The recall covers 2,474 units distributed worldwide, including the United States, Guam, Puerto Rico, and numerous international countries. Healthcare facilities should contact GE Healthcare for instructions on how to address the affected devices.

The recalled product

Product
GE Healthcare Infinia Hawkeye 4 Option For Dual-Head Variable Angle Gamma Camera, Hawkeye Option for Dual-Head Variable Angle Gamma Camera (this includes GE Quasar Nuclear Medicine Systems). Nuclear Medicine Systems Infinia devices Product Usage: The intended use of the Qua
Manufacturer
GE Healthcare, LLC
Category
Medical Device — Nuclear Medicine Imaging
Hazard
Affected units
2,474

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • System ID: 1153389
  • 1299296
  • 2555007
  • 2621801
  • 2638808
  • 2694593
  • 2760723
  • 2768147
  • 2769200
  • 2775945
  • 2812777
  • 2827087
  • 2883051
  • 0828260003
  • 0828260005
  • 0828260006
  • 0828260007
  • 0828260009
  • 0828260011
  • 0828260013

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Part of a larger recall action

This product is one of 7 recalled by GE Healthcare, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 7 products in this recall →

Related recalls

Same manufacturer · GE Healthcare, LLC

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Same hazard · patient death

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