Severe FDA (Devices)·Z-1054-2023·Announced 2023-02-15

GE Nuclear Medicine Systems: Detector Fall Risk Due to Faulty Mitigation

GE Nuclear Medicine 600/800 series systems (748 units distributed worldwide) may have improperly implemented detector fall mitigations. If the mitigation fails, the detector can fall and cause life-threatening bodily 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 classification requires a minimum severity score of 4. The hazard poses risk of life-threatening bodily injury from equipment failure, though no injuries have been reported.

Plain-English summary

GE Nuclear Medicine 600/800 series emission computed tomography systems are subject to this Class I recall. The recall affects 748 units distributed worldwide, including installations throughout the United States, Puerto Rico, and numerous international locations.

The safety mitigation designed to prevent detector falls may not be correctly implemented on affected units. If the mitigation fails, the detector assembly can fall, creating a risk of life-threatening bodily injury to patients and medical personnel in the vicinity.

Affected facilities can identify their systems using the provided serial numbers and catalog numbers. Specific affected model variants and their identifiers are listed by the manufacturer, GE Medical Systems Israel.

The recalled product

Product: GE Nuclear Medicine 600/800 series systems, specifically: a) 830, b) 830 / Dismount, c) 830 /, d) 830 / 5842894-20, e) 830 / Dismount / 50HZ, f) 830 / Dismount / 60HZ, g) 830 3/8 inch Detector, h) 830 BJ, i) 830 BJ / 5144407, j) 830 BJ / Dismount, k) 830 ES DEM, l) 8
Manufacturer: GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Category: Medical Device — Nuclear Medicine Imaging
Hazard: detector-fall
serious-injury
Affected units: 748

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) 830: Catalog number To be provided
UDI/DI Not Applicable
Serial Numbers: NT3AG2200003
NT3AG2000015BH
NT3AG2100015BH
NT3AG2200006BH
b) 830 / Dismount: Catalog number To be provided
Serial numbers: NT3AG2100016BH
c) 830 /: Catalog number To be provided
Serial Numbers: NT3AG2100009BH
d) 830 / 5842894-20: Catalog number To be provided
Serial Numbers: NT3AG2200013
e) 830 / Dismount / 50HZ: Catalog number To be provided
Serial Numbers: NT3AG2000017BH
f) 830 / Dismount / 60HZ: Catalog number To be provided
Serial Numbers: NT3AG2100001
g) 830 3/8 inch Detector: Catalog number H3910AC
Serial Numbers: 830Y60105
h) 830 BJ: Catalog number To be provided
Serial Numbers: NT3AG1900009BH

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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