GE Nuclear Medicine 600/800 Systems Recalled for Detector Fall Risk

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 ROW,

Manufacturer

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

Category

Medical Device — Diagnostic Imaging / Nuclear Medicine

Hazard

• detector-fall
• mechanical-failure
• injury

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

Distributed nationwide across the United States.

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