Recall Z-1688-2012 ยท JAK System, X-Ray, Tomography, Computed
Philips Medical Systems (Cleveland) Inc
The Brilliance iCT and iCT SP are Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
| Date | May 30, 2012 (initiated May 7, 2012) |
| Status | Terminated |
| Reason | On 3/5/2012, Philips Healthcare was notified of one incident involving a Brilliance iCT scanner that resulted in damage to the gantry and slight injury to the user when the heat exchanger detached from the cooling unit due to some missing welds. |
| Root cause | Nonconforming Material/Component |
| Action | Philips Healthcare sent an "URGENT- MEDICAL DEVICE CORRECTION" letter dated May 8, 2012 to all affected customers. The letter identifies the product and problem. No action is required by the customers. Additionally, a Field Service Engineer will contact each site to schedule time to implement the Field Change Order. Philips Healthcare will inspect the cooling units on all iCT and iCT SP systems for this issue and if the welds on a cooling unit do not pass the inspection, Philips will replace the cooling unit free of charge. |
| Quantity | 372 |
| Distribution | Worldwide Distribution-USA (nationwide) including the states of AL, AR, AZ, CA, DC, DE, FL, GA, IA, IL, IN, KY, MA, MD, MN, MO, MS, NC, NV, NY, OH, OK, OR, PA, PR, SC, TN, TX, VT, WA and WV and the countries of Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, Chile, China, Czech |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060937 | BRILLIANCE VOLUME Philips Medical Systems (Cleveland), Inc., Jun 5, 2006 |