Precedence 16 (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Im
FDA device recall Z-1778-2015 · posted 2015-06-11 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Reason for recall
- The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overheating and/or emission of fumes.
- Action taken
- On 3/9/2015 the firm sent Urgent Field Safety Notices Medical Device Correction letters to their customers.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- KPS
- Quantity affected
- 36 units
- Distribution
- Worldwide Distribution-US (nationwide) including DC & Puerto Rico and the following countries: Albania, Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Bulgaria, Cambodia
- Date initiated
- 2015-03-06
- Date posted
- 2015-06-11
- Date terminated
- 2017-03-13
- Location
- Cleveland, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GRIFFIN SPECT/CT IMAGING SYSTEM (K041218) | Adac Laboratories | 2004-05-24 |