GE Healthcare Recalls Discovery NM 630 Nuclear Imaging Systems
GE Healthcare is recalling 108 Discovery NM 630 nuclear imaging systems worldwide due to a failure mode that can cause serious injury or death.
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, and the recall is issued because serious injuries or deaths could occur. Per the rubric, known fatalities mandate a score of 5.
Plain-English summary
GE Healthcare, LLC is recalling 108 units of the Discovery NM 630 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 used by trained healthcare professionals to detect, localize, and diagnose diseases and assess 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. The source text does not specify the exact nature of the failure mode or the specific injuries involved.
Healthcare facilities that possess these systems should contact GE Healthcare for instructions on how to address the recall. The recall includes specific system IDs listed in the official documentation. Consumers and patients should consult their healthcare providers regarding the status of their imaging equipment.
The recalled product
- Product
- Discovery NM 630, dual detector free-geometry integrated nuclear imaging system. Product Usage: The GE Discovery NM 630 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and…
- Manufacturer
- GE Healthcare, LLC
- Affected units
- 108
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: 0850260134
- 083026001113611
- 00001NUC11
- 00052NUC11
- 030029NU05
- 030151NU15
- 030359NU07
- 201418D630
- 205333D630
- 207664NM630
- 208455NM630
- 217544PH630
- 251639D630
- 262574D630
- 269945D630
- 270417D630
- 281540D630
- 301877D630
- 305596D630A
- 305596D630B
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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