Severe FDA (Devices)·Z-1057-2023·Announced 2023-02-15

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
Category: Medical Device — Nuclear Medicine Imaging
Hazard: detector-fall
bodily-injury
Affected units: 86

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.

The notice also names 1 state specifically:

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.

See all 6 products in this recall →

Same manufacturer · GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

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