Recall Z-0899-2013 ยท JAK System, X-Ray, Tomography, Computed
Philips Medical Systems (Cleveland) Inc
Philips MX 16-Slice CT Scanner System, a whole-body computed tomography X-ray system.
| Date | Feb 28, 2013 (initiated Dec 19, 2012) |
| Status | Terminated |
| Reason | The four screws that secure the patient table top to the carrier became loose, which caused the table top to detach. |
| Root cause | Component design/selection |
| Action | Philips Healthcare sent an Urgent - Medical Device Correction letter dated December 14, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to have BioMedical Engineering personnel inspect the patient table top screws that secure it to the carrier. Customers were instructed that If it is found that the table top screws are improperly seated, they should stop using the system and contact their local Philips Field Service Engineer for repair. A Philips Field Service Engineer will schedule a tim |
| Quantity | 412 Units |
| Distribution | Worldwide Distribution - USA including AL, AR, CA, FL, GA, IL, IN, KY, MI, MS, NC, NJ, NV, NY, OH, PA, PR and VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K083498 | PHILIPS MODEL MX 16 SLICE CT SYSTEM Philips Medical Systems (Cleveland), Inc., Dec 17, 2008 |