Philips MX 16-Slice CT Scanner System, a whole-body computed tomography X-ray system.
FDA Recall Z-0899-2013 · Posted 2013-02-28
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Recalling FirmPhilips Medical Systems (Cleveland) Inc
Recall StatusTerminated
Product CodeJAK
Date Initiated2012-12-19
Date Terminated2013-12-03
Product Quantity412 Units
Reason for Recall
The four screws that secure the patient table top to the carrier became loose, which caused the table top to detach.
Firm 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 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
Distribution Pattern
Worldwide Distribution - USA including AL, AR, CA, FL, GA, IL, IN, KY, MI, MS, NC, NJ, NV, NY, OH, PA, PR and VA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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