Agency classClass IOur severity:Severe FDA (Devices)·Z-1058-2023·Announced 2023-02-15

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.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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…
Manufacturer: GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Category: Medical Device — Diagnostic Imaging / Nuclear Medicine
Hazard: detector-fall
mechanical-failure
injury
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

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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