GE Nuclear Medicine 600/800 Systems Recalled for Detector Fall Risk
GE Medical Systems is recalling 380 GE Nuclear Medicine 600/800 series diagnostic imaging systems worldwide due to potential failure in detector mitigation that could allow the detector to fall, risking life-threatening injury.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I designation requires minimum severity level 4. The recall identifies a potential for life-threatening bodily injury if the detector mitigation mechanism fails, though no injuries have been reported.
Plain-English summary
GE Medical Systems Israel is recalling 380 GE Nuclear Medicine 600/800 series systems, including multiple model variants such as NM/CT 850, NM/CT 860, NM 830, and their variants with different gantry configurations. These are diagnostic imaging devices used in nuclear medicine and computed tomography applications.
The recall is classified as FDA Class I due to a potential failure in detector mitigation. If the mitigation is not correctly implemented, the detector assembly can fall, which may lead to life-threatening bodily injury.
The affected systems have been distributed worldwide, including throughout the United States and Puerto Rico, as well as numerous additional countries and territories.
The recalled product
- Product
- GE Nuclear Medicine 600/800 series systems, specifically: a) 850, b) 850 / Dismount, c) 850 3/8 inch NM Gantry, d) 860 / Dismount, e) 860 3/8 inch NM Gantry, f) 860 5/8 inch NM Gantry, g) 860 BJ, h) NM 830 3/8 inch BJ, i) NM/CT 850 3/8 inch BJ, j) NM/CT 850 3/8 inch ROW,
- Manufacturer
- GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
- Affected units
- 380
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)
- a) 850: Catalog number 5376204-50-1
- UDI/DI Not Applicable
- Serial Numbers: NT3BG2200006BH
- b) 850 / Dismount: Catalog number To be provided
- Serial Numbers: NT3BG2100003BH
- c) 850 3/8 inch NM Gantry: Catalog number H3907AD
- Serial Numbers: 85EY67037
- 850Z61033
- 85EY67039
- 85EY67048
- 850Y61018
- 850Y61009
- 85EY67035
- 85EX67001
- 85EX67020
- 85EY67045
- 85EX67023
- 85EY67032
- 85EY67046
- 850A61063
Distribution
Part of a larger recall action
This product is one of 6 recalled by GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 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.
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