GE Nuclear Medicine Systems Recall Due to Potential Detector Fall Hazard
GE is recalling 86 Nuclear Medicine 600/800 series systems worldwide due to a potential failure in a safety mitigation. If not correctly implemented, the detector can fall and cause 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: This is an FDA Class I recall, which mandates a minimum severity score of 4 per the rubric. No illnesses or injuries have been reported, preventing a Score 5 classification for actual harm.
Plain-English summary
GE Medical Systems Israel, Functional Imaging, is recalling 86 units of GE Nuclear Medicine 600/800 series systems. Affected models include the 870 CZT O540+ Gantry 7.25mm, D670 CZT Gantry 7.25mm, Discovery NMCT 670 CZT O540+, and several NM/CT 870 CZT variants.
These systems have been distributed worldwide, including throughout the United States and Puerto Rico, as well as in countries across Europe, Asia, the Middle East, Africa, and Latin America.
The recall addresses a potential failure in a safety mitigation mechanism. If the mitigation is not correctly implemented, the detector assembly can fall, which could result in life-threatening bodily injury.
The recalled product
- Product
- GE Nuclear Medicine 600/800 series systems, specifically: a) 870 CZT O540+ Gantry 7.25mm, b) D670 CZT Gantry 7.25mm, c) DISCOV NM/CT 870 CZT, d) Discovery NMCT 670 CZT O540+, e) NM/CT 870 CZT CYBER DEFENCE, f) NM/CT 870 CZT O540, g) NM/CT 870 CZT WSO, h) NM/CT 870 CZT, i
- Manufacturer
- GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
- Hazard
- detector-fall
- bodily-injury
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) 870 CZT O540+ Gantry 7.25mm: Catalog number H3906CW
- UDI/DI 01008406821408432187CZ6304211200300
- Serial Numbers: 87CZ63042
- UDI/DI 01008406821408432187CA6305311210100
- Serial Numbers: 87CA63053
- UDI/DI 01008406821408432187CX6301111181000
- Serial Numbers: 87CX63011
- UDI/DI 01008406821408432187CY6302011190300
- Serial Numbers: 87CY63020
- UDI/DI 01008406821408432187CY6303511191100
- Serial Numbers: 87CY63035
- UDI/DI 01008406821408432187CZ6304011200100
- Serial Numbers: 87CZ63040
- UDI/DI 01008406821408432187CX6300411180700
- Serial Numbers: 87CX63004
- UDI/DI 01008406821408432187CX6300911180900
- Serial Numbers: 87CX63009
- UDI/DI 01008406821408432187CB6307211220700
- Serial Numbers: 87CB63072
- UDI/DI 01008406821408432187CA6306111211100
Distribution
Distributed nationwide across the United States.
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