Severe FDA (Devices)·Z-1053-2023·Announced 2023-02-15

GE Nuclear Medicine 600/800 Series Systems Detector Fall Risk

GE Nuclear Medicine 600/800 series systems have a safety mitigation that may not be correctly implemented, allowing the detector to fall and cause life-threatening injury. 557 units are affected worldwide.

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 mandates a minimum Severe rating. Although no deaths or injuries are reported in the source, the hazard explicitly describes a risk of life-threatening bodily injury, justifying the Severe (4) classification.

Plain-English summary

GE Medical Systems Israel's Nuclear Medicine 600/800 series imaging systems, with 557 units distributed worldwide, are the subject of this FDA Class I recall.

The recall concerns a potential failure in a safety mitigation measure related to the detector. If the mitigation is not correctly implemented, the detector can fall, which could result in life-threatening bodily injury.

These systems have been distributed worldwide, including throughout the United States, Puerto Rico, and numerous countries globally.

Facilities using these systems should contact GE Medical Systems for information about remediation and corrective actions. Due to the serious nature of the potential hazard, the FDA has issued this Class I recall.

The recalled product

Product: GE Nuclear Medicine 600/800 series systems, specifically: a) 870, b) 870 DR 3/8 inch NM GANTRY WITH NEW ROTOR - MEA, c) 870 DR / Dismount, d) 870 DR / Dismount / 60HZ, e) 870 DR 3/8 inch WSO, f) 870 DR 3/8 inch NM Gantry, g) 870 DR 3/8 inch, h) 870 DR 3/8 inch CH, i) 8
Manufacturer: GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Category: Medical Device — Nuclear Medicine Imaging Equipment
Hazard: fall-hazard
life-threatening-injury
Affected units: 557

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: Catalog number To be provided
UDI/DI Not Applicable
Serial Numbers: NT3DG2200004
NT3DG2200009
NT3DG2200018
NT3DG2200002
b) 870 DR 3/8" NM GANTRY WITH NEW ROTOR - MEA: Catalog number 5376204-70-60-1
Serial Numbers: NT3DG2100018BH
c) 870 DR / Dismount: Catalog number To be provided
UDI/DI To be provided
Serial Numbers: NT3DG2100006
d) 870 DR / Dismount / 60HZ: Catalog number To be provided
Serial Numbers: NT3DG2000016BH
e) 870 DR 3/8" WSO: Catalog number H3906EM
Serial Numbers: 870B64224
870Z64148
f) 870 DR 3/8" NM Gantry: Catalog number H3100AS
Serial Numbers: 870Y64064
870Y64040
870A64172

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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