Positron Emission Tomography (PET) and X-ray Computed Tomography, GEMINI TF 16 PET/CT, GEMINI GXL 16 PET/CT, GEMINI TF B
FDA device recall Z-2239-2012 · posted 2012-08-22 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Reason for recall
- 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.
- Action taken
- 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. .
- Root cause
- Material/Component Contamination
- Status
- Terminated
- Product code
- KPS
- Quantity affected
- 7 units
- Distribution
- Nationwide Distribution-including the states of CO, FL, MD, MN, NE and PA.
- Date initiated
- 2012-08-08
- Date posted
- 2012-08-22
- Date terminated
- 2014-04-28
- Location
- Cleveland, OH
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GEMINI CONDOR (K081135) | Philips Medical Systems (Cleveland), Inc. | 2008-04-29 |
| GEMINI RAPTOR (K052640) | Philips Medical Systems (Cleveland), Inc. | 2005-10-07 |
| GEMINI GXL (K051170) | Philips Medical Systems (Cleveland), Inc. | 2005-05-23 |