Philips Digital Diagnost-Mobile Detector Holder for Digital Diagnost (Single Detector, Dual Detector, Release 3) System
FDA device recall Z-2465-2012 · posted 2012-09-27 · Terminated
Recall details
- Recalling firm
- Philips Healthcare Inc.
- Reason for recall
- The Wireless Portable Detector (WPD) is not fixed securely inside the Mobile Detector Holder and may fall down
- Action taken
- Philips Healthcare sent a Urgent Field Safety Notice dated August 13, 2012, to all affected customers. Notifications began the week of September 6, 2012, for US and Worldwide Customers. The letter identified the product the problem and the action needed to be taken by the customer. Philips field service engineer will Secure the 4 countersunk screws, which are used to attach the lock mechanism, with thread locker (loctite). Further information or support concerning this issue, contact your local Philips representative. 1-800-722-9377.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- MQB
- Quantity affected
- 93 Units
- Distribution
- Worldwide Distribution--USA (nationwide) and the countries of Australia, Austria, Canada, Chile, Finland, France, Germany, Hungary. Italy, Japan, Latvia, Netherlands, New Zealand. Oman, South Korea, S
- Date initiated
- 2012-09-06
- Date posted
- 2012-09-27
- Date terminated
- 2017-01-17
- Location
- Andover, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PHILIPS BUCKY VISION (K982795) | Philips Medical Systems, Inc. | 1998-11-24 |