GE Healthcare Recalls Nuclear Medicine Imaging Systems Due to Patient Death
GE Healthcare is recalling 213 Discovery NM/CT 670 systems worldwide after a patient died from injuries sustained during a scan on a related system.
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 213 units of the Discovery NM/CT 670 dual detector free-geometry integrated nuclear imaging system. The recall covers systems distributed worldwide, including the United States, Guam, Puerto Rico, and numerous international locations. The product is a medical tool intended for use by trained healthcare professionals to aid in detecting, localizing, and diagnosing diseases and organ function.
The recall was initiated after GE became aware of an incident at a US VA Medical Center where a patient died due to injuries sustained while being scanned on an Infinia Hawkeye 4 Nuclear Medicine System. GE notified hospitals that the recall is necessary because serious injuries or deaths could occur due to a failure mode associated with the recalled systems.
Healthcare facilities and consumers should stop using the affected Discovery NM/CT 670 systems immediately. The specific System IDs for the affected units are listed in the official recall documentation. Users should contact GE Healthcare for further instructions on the recall process.
The recalled product
- Product
- Discovery NM/CT 670 dual detector free-geometry integrated nuclear imaging system. Product Usage: The GE Discovery NM/CT 670 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases…
- Manufacturer
- GE Healthcare, LLC
- Affected units
- 213
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: 0828260021
- 0828260022
- 0850260118
- 0850260122
- 0850260128
- 0850260131
- 0850260132
- 0853260094
- 0853260099
- 0856260033
- 0856260034
- 0856260035
- 0910262297
- 0910262304
- 0910262310
- 0910262319
- 0910262322
- 0910262325
- 0910262344
- 0910263223
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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