Philips MX 16-Slice CT Scanner System, a whole-body computed tomography X-ray system.
FDA device recall Z-0899-2013 · posted 2013-02-28 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Reason for recall
- The four screws that secure the patient table top to the carrier became loose, which caused the table top to detach.
- Action taken
- 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 time to inspect and repair all the affected systems. For further information customers were instructed to contact their Philips Healthcare Customer Care Solutions Center at 1-800-722-9377 and follow the recorded menu option to reach a Customer Solutions. For questions regarding this recall call 800-722-9377, ext 5.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- JAK
- Quantity affected
- 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.
- Date initiated
- 2012-12-19
- Date posted
- 2013-02-28
- Date terminated
- 2013-12-03
- Location
- Cleveland, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PHILIPS MODEL MX 16 SLICE CT SYSTEM (K083498) | Philips Medical Systems (Cleveland), Inc. | 2008-12-17 |