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

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

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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