The Recall Desk
CriticalFDA (Devices)·Z-1788-2013·Announced 2013-07-31

GE Healthcare Recalls Nuclear Medicine Imaging Systems Due to Patient Death

GE Healthcare is recalling Varicam/VG and VG Hawkeye devices 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, if reported deaths exist anywhere in the source text, the score is 5 regardless of other factors.

Plain-English summary

GE Healthcare, LLC is recalling 571 units of Varicam/VG and VG Hawkeye devices, including the Infinia Hawkeye 4 Nuclear Medicine System. These devices are intended for general Nuclear Medicine imaging procedures to detect radioisotope tracer uptake in the patient body.

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

The affected devices were distributed worldwide, including the US nationwide, Guam, Puerto Rico, and numerous international countries. Consumers and healthcare facilities should contact GE Healthcare for further instructions regarding the recall and replacement or repair of the affected units.

The recalled product

Product
GE Healthcare Varicam/VG and VG Hawkeye devices Product Usage: The intended use of the Quasar system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by vario
Manufacturer
GE Healthcare, LLC
Category
Medical Device — Nuclear Medicine Imaging
Hazard
Affected units
571

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: 2998
  • 6970
  • 12865
  • 21414
  • 38070
  • 53263
  • 55461
  • 56948
  • 58230
  • 58378
  • 58379
  • 58483
  • 58510
  • 58582
  • 58622
  • 58630
  • 58711
  • 58785
  • 58797
  • 58808

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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