—#132293

Product

The Revolution CT is a multi-slice (256 detector row) CT scanner consisting of a gantry, patient table, scanner desktop (operator console), system cabinet, power distribution unit (POU). and interconnecting cables.The system includes image acquisition hardware, image acquisition and reconstruction software, and associated accessories.

FDA product code: JAK — System, X-Ray, Tomography, Computed
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K133705
Affected lot / code info: Software version: 14MW14.29

Why it was recalled

A required quality control test was not performed during installation associated with the software of the Revolution CT scanner.

Root cause (FDA determination)

Radiation Control for Health and Safety Act

Action the firm took

GE Healthcare Planned Action (s) to repair defect or to bring product into Compliance letter dated January 16, 2015 to GE Healthcare. 1. A GE Healthcare service representative will perform a noise specification and tolerance calibration to correct all affected systems via Field Action Instruction (FMI 25457). 2. A customer notification letter which includes a statement that GE Healthcare will without charge, remedy the defect or bring the product into compliance. CDRH approves the CAP subject to the following conditions: 1. Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification. 2. GE Healthcare Surgery will implement this CAP by May 1, 2015. You may proceed or continue with implementation of the CAP (subject to the conditions noted above). Call Center phone numbers: United States: 800 437-1171, Japan: 0120-055-919 Information For other countries, please contact your local GE Healthcare Service Representative if you have any questions or concerns regarding this notification.

Recalling firm

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

Distribution

Distribution pattern: US Distribution to the states of CA, FL, IL, NY, UT and WA.

Timeline

Recall initiated: 2014-11-12
Posted by FDA: 2015-01-26
Terminated: 2015-04-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #132293. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.