GE Nuclear Medicine Imaging Systems detector fall hazard

Plain-English summary

GE Medical Systems Israel has issued a Class I recall affecting 34 units of Nuclear Medicine 600/800 series imaging systems, including the OPTIMA O640, DISCOVERY O640, and related models. These devices are Emission Computed Tomography systems used in medical facilities for diagnostic imaging.

The recall was issued because a required safety mitigation may not be correctly implemented. If the mitigation is not properly in place, the detector could fall, creating a risk of life-threatening bodily injury to patients, staff, or others near the equipment.

The affected units have been distributed worldwide, including throughout the United States and Puerto Rico, as well as in numerous countries internationally as documented in the FDA recall notice.

Facilities with affected equipment can verify whether their system is included by checking the serial numbers and catalog numbers listed in FDA recall notice Z-1056-2023. Affected facilities should contact GE Medical Systems Israel to ensure the required mitigation has been correctly implemented.

The recalled product

Product

GE Nuclear Medicine 600/800 series systems, specifically: a) OPTIMA O640 X 3/8 inch NR, b) DISCOVERY O640 X 3/8 inch, c) NM OPTIMA O640 X 3/8 inch, d) O640 NM Gantry 3/8 inch, e) O640 NM GANTRY FINAL ASSY, f) OPTIMA O640 X 3/8 inch; Emission Computed Tomography System

Manufacturer

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

Category

Medical Device — Diagnostic Imaging

Hazard

• fall-hazard
• bodily-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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