GEMINI TF 16 PET/CT System & GEMINI TF 64 PET/CT System, Philips Medical Systems, Cleveland, OH The device is a diagnost
FDA device recall Z-0937-2012 · posted 2012-02-02 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Reason for recall
- Philips became aware of an issue relating to a UPS cabinet that contained a melted battery which caused damage to other batteries lower in the cabinet, leading to battery acid leaking on the floor.
- Action taken
- Philips Medical Systems (Cleveland) Inc communitcated the problem to the facilities via telephone. No customer letter was sent since the correction was already performed by the supplier.
- Root cause
- Material/Component Contamination
- Status
- Terminated
- Product code
- KPS
- Quantity affected
- 2
- Distribution
- Nationwide Distribution including Maryland and Colorado
- Date initiated
- 2011-10-24
- Date posted
- 2012-02-02
- Date terminated
- 2013-06-18
- Location
- Cleveland, OH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GEMINI RAPTOR (K052640) | Philips Medical Systems (Cleveland), Inc. | 2005-10-07 |