Recall Z-1820-2011 ยท JAK System, X-Ray, Tomography, Computed
Philips Medical Systems (Cleveland) Inc
Brilliance 64 S/N 9089, 9551, 9548. The Brilliance 64 is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
| Date | Mar 24, 2011 (initiated Dec 20, 2010) |
| Status | Terminated |
| Reason | During the version 2.6 software upgrade, the system was not recalibrated with the infant phantom for the infant protocol. |
| Root cause | Other |
| Action | Philips sent an URGENT - Medical Device Correction letter dated January 31, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers may consider reviewing any infant images that may have been affected during the Field Test to confirm reading accuracy. For further information or support concerning this issue, customers could contact their local Philips representative or local Philips Healthcare office for North America and Canada contact the Customer Care Solutions Center (1-800-722-9377, option 5: Enter Site ID |
| Quantity | 3 |
| Distribution | Worldwide Distribution - USA including CO, IN, and TN and the countries of Norway, Israel, and Germany |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K033326 | PHILIPS PLUS COMPUTED TOMOGRAPHY SYSTEM Philips Medical Systems, Inc., Oct 29, 2003 |