Recall Z-2239-2012 ยท KPS System, Tomography, Computed, Emission
Philips Medical Systems (Cleveland) Inc
Positron Emission Tomography (PET) and X-ray Computed Tomography, GEMINI TF 16 PET/CT, GEMINI GXL 16 PET/CT, GEMINI TF Big Bore PET/CT, Philips Medical Systems, Cleveland, OH. The device is a diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem produces cross-sectional images of
| Date | Aug 22, 2012 (initiated Aug 8, 2012) |
| Status | Terminated |
| Reason | Philips became aware of an issue relating to a UPS battery cabinet that appeared to have burned a hole through the casing on one of the batteries. Supplier of the UPS, Chloride/Emerson, determined the batteries, housed within the UPS battery cabinet, entered thermal runaway causing the battery to overheat. |
| Root cause | Material/Component Contamination |
| Action | Philips Healthcare sent an "URGENT-MEDICAL DEVICE CORRECTION" letter dated August 8, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. Field Service Engineers will be implementing a Field Change Order (FCO) to replace the batteries of the affected UPS units. Contact the Philips Healthcare Customer Care Solutions Center at 1-800-722-9377 for questions regarding this notice. . |
| Quantity | 7 units |
| Distribution | Nationwide Distribution-including the states of CO, FL, MD, MN, NE and PA. |
| FDA record | Open on fda.gov |