Recall Z-2210-2013 ยท JAK System, X-Ray, Tomography, Computed
Philips Medical Systems (Cleveland) Inc
Brilliance CT 6, M/N 728256; Brilliance CT 16 M/N 728246; Brilliance CT 40, M/N 728235 & Brilliance CT 64 M/N 728231, Philips Healthcare, Cleveland, OH 44143. Intended to produce cross-sectional images of the body by computer reconstruction.
| Date | Sep 16, 2013 (initiated Jul 5, 2013) |
| Status | Terminated |
| Reason | The patient support may move in an unintended manner if the footswitch cover impinges on the footswitch. |
| Root cause | Component design/selection |
| Action | Philips Healthcare sent an "URGENT-MEDICAL DEVICE CORRECTION" letter dated June 4, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact the Customer Care Center at 1-800-722-9377, option 5 for information concerning this issue. |
| Quantity | M/N: 728256, 4 units; M/N: 728246, 89 units; M/N: 728235, 9 units & M/N: 728231, 207 units |
| Distribution | Worldwide Distribution-USA (nationwide) including DC and the states of AL, AR, AZ, CA, CO, DE, FL, GA, IN, KY, MA, MD, MI, MN, MS, NC, NM, NV, NY, OH, OK, PA, SC, TN, TX, VT, WI & WV, and the countries of Australia, Austria, Bosnia & Herzegovina, Chile, China, Croatia, Denmark, Equatorial Guinea, Fr |
| FDA record | Open on fda.gov |