—#192374

Product

Revolution Apex, Revolution CT with Apex Edition

FDA product code: JAK — System, X-Ray, Tomography, Computed
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K163213, K191777
Affected lot / code info: Revolution Apex, Revolution CT with Apex Edition

Why it was recalled

The accumulated dose is incorrectly displayed in certain situations. There are two situations that will result in the SmartStep displayed dose being inaccurately high.

Root cause (FDA determination)

Radiation Control for Health and Safety Act

Action the firm took

GE Healthcare sent an Important Electronic Product Radiation Warning letter dated February 8, 2022 to all affected systems informing its users of the potential for the issue to occur and instruct the users as to what actions to take. GE Healthcare will, without charge, remedy the defect or bring the product into compliance with each applicable Federal standard in accordance with a plan to be approved by the Secretary of Health and Human Services, the details of which will be included in a subsequent communication to you or through a GE Healthcare field engineer site visit. For questions contact GE Healthcare Services at 1 (800) 437-1171 or local Service Representative.

Recalling firm

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

Distribution

Distribution pattern: Worldwide - US Nationwide distribution.

Timeline

Recall initiated: 2021-06-30
Posted by FDA: 2022-04-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #192374. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.