GE Nuclear Medicine 600/800 Series Systems Detector Fall Risk

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

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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