SKYLight Gamma Camera System; SKYLIGHT,AZ,9FT,3/8 Manufactured by Philips Medical Systems (Cleveland), Inc. 595 Miner Ro
FDA device recall Z-0253-2012 · posted 2011-11-19 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems
- Reason for recall
- A mechanical malfunction of the button on the hand controller on the Philips Precedence and SKYLight SPECT systems may get stuck and cause unintended motion of a detector.
- Action taken
- Philips Medical Systems sent a "Customer Information" letter dated September 27, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter lists additional precautions the customers should use while operating the device. Philips will notify customers for replacing the affected product through an Action for Performance-Proactive Field Change Order to resolve the issue. Contact Philips Customer Care Solutions at 1-800-722-9377, option 5, for questions concerning this notice.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- KPS
- Quantity affected
- 658 - all units in recall
- Distribution
- Worldwide Distribution-USA (nationwide) including Puerto Rico.
- Date initiated
- 2011-09-27
- Date posted
- 2011-11-19
- Date terminated
- 2012-12-21
- Location
- San Jose, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SKYLIGHT IMAGING SYSTEM (K000908) | Adac Laboratories | 2000-04-05 |