Agency classClass IOur severity:Critical FDA (Devices)·Z-1789-2013·Announced 2013-07-31

GE Healthcare Recalls Elscint APEX Helix Gamma Cameras Due to Patient Death

GE Healthcare is recalling 50 Elscint APEX Helix gamma cameras worldwide after a patient died from injuries sustained during a scan at a US VA Medical Center.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. 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 during a scan, which meets the rubric criterion for a score of 5 (Critical) due to known fatalities.

Plain-English summary

GE Healthcare, LLC is recalling 50 units of the Elscint APEX Helix dual-head, multi-purpose, Slip-Ring, digital gamma camera. The recall is being conducted worldwide, including the United States, Guam, Puerto Rico, and numerous international locations. The affected devices are used for general Nuclear Medicine imaging procedures to detect radioisotope tracer uptake in patients.

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 source text does not specify the exact nature of the injuries or the mechanical failure that led to the incident.

Healthcare facilities should contact GE Healthcare for instructions on how to stop using the affected devices and arrange for repair or replacement. Consumers and patients should consult their healthcare providers regarding the safety of their imaging equipment.

The recalled product

Product: Elscint APEX Helix, dual-head, multi-purpose, Slip-Ring, digital gamma camera 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…
Manufacturer: GE Healthcare, LLC
Category: Medical Device — Nuclear Medicine Imaging
Hazard: patient-injury
death
Affected units: 50

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: 57503
57584
57588
57711
57727
57734
57815
57873
58826
0828960002
082426010006
082426130005
082426160008
00243NUC09
0090J
0177A
0201B
0252A
0272B
0274B

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 →

Same manufacturer · GE Healthcare, LLC

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