—#174385

Product

Revolution CT scanners Product Usage: The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.

FDA product code: JAK — System, X-Ray, Tomography, Computed
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K133705, K163213
Affected lot / code info: Revolution CT

Why it was recalled

Additional low dose radiation exposure.

Root cause (FDA determination)

Device Design

Action the firm took

GE Healthcare will send a customer letter that provide safety instructions for immediate mitigation of the issue. The customer can continue to use the system with the recommended workaround instruction provided in the customer letter: All affected systems will be corrected with updated software and a User Manual Addendum which re-emphasizes existing pat ient center ing instructions. If you have any questions or concerns regarding this notification. For question 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 - US Nationwide Distribution

Timeline

Recall initiated: 2019-01-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #174385. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.