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.
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 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…
- Manufacturer
- GE Healthcare, LLC
- 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
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
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