BrightView Gamma Camera Radius Drive Assembly, manufactured by Philips Medical Systems (Cleveland) Inc., Cleveland, OH,
FDA device recall Z-1892-2009 · posted 2009-09-16 · Terminated
Recall details
- Recalling firm
- Phillips Nuclear Medicine
- Reason for recall
- Unexpected movement-- if the drive assembly is severely compromised, the detector may slide to its hardware limit.
- Action taken
- Firm initiated its recall notification on July 6, 2009 issuing a field safety notice to its consignees via FedEx and internationally through its personnel. Responses will be tracked for effectiveness. Questions may be directed to Philips Customer Care Center at 1.800.722.9377.
- Root cause
- Process control
- Status
- Terminated
- Product code
- KPS
- Quantity affected
- 288 units
- Distribution
- Worldwide
- Date initiated
- 2009-07-02
- Date posted
- 2009-09-16
- Date terminated
- 2010-04-12
- Location
- Milpitas, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| APOLLO GAMMA CAMERA SYSTEM (K062298) | Adac Laboratories | 2006-08-23 |