—#187101

Product

NM/CT 850 Nuclear Medicine / CT Scanners

FDA product code: KPS — System, Tomography, Computed, Emission
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K173816
Affected lot / code info: GTIN*00840682140775

Why it was recalled

GE Healthcare has become aware of a potential issue on 800 family NM/CT Scanners that could cause a shift in CT radiation exposure range of up to 5cm compared to the intended radiation exposure range of the planned scan under specific workflows. The issue occurs only on a hybrid whole-body continuous F3 protocol with Zoom < 1 where the scan range is set on the Smart Console. In some cases, this may also necessitate a re-scan of the patient, which would expose the patient to additional X-ray radiation.

Root cause (FDA determination)

Device Design

Action the firm took

GE Healthcare will send a customer notification letter describing the issue and providing safety instructions for immediate mitigation of the issue. Customers were instructed, they may continue to use the system and follow workaround instructions (zoom=1 for specific WB protocol) until the correction is provided. GE Healthcare corrective action is the development and deployment of a software update on all affected smart console IB systems at no cost to the customer. For questions contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.

Recalling firm

Firm: GE Healthcare, LLC
Address: 3000 N Grandview Blvd, Waukesha, Wisconsin 53188-1615

Distribution

Distribution pattern: Worldwide distribution - US Nationwide

Timeline

Recall initiated: 2021-02-07
Posted by FDA: 2021-05-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #187101. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.