—#190306

Product

Computed Tomography Systems Revolution CT, Revolution CT ES, 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: K133705, K163213, K191777
Affected lot / code info: Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition

Why it was recalled

The accumulated dose is incorrectly displayed in certain situations. Thisoccurs during an interventional exam using the SmartStep option if the table height is adjusted after the exam starts. In this situation, the SmartStep display will show a value that is higher (up to 100 times) than the actual dose delivered.

Root cause (FDA determination)

Radiation Control for Health and Safety Act

Action the firm took

GE sent an Important Electronic Product Radiation Warning Notification letter dated October 4, 2021 to customers, The letter identified the affected product, problem and actions to be taken. Customers were informed that 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 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 and US Nationwide Distribution

Timeline

Recall initiated: 2021-06-30
Posted by FDA: 2021-11-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #190306. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.