Actuator for angiographic x-ray monitor ceiling suspension system. Actuator short Assy: THC8AWDS-121 and Actuator long A
FDA device recall Z-0810-2016 · posted 2016-02-16 · Terminated
Recall details
- Recalling firm
- Philips Electronics North America Corporation
- Reason for recall
- The actuator assembly became detached and the monitor carriage with a flexvision monitor dropped to its lowest position.
- Action taken
- Philips sent a Field Safety Notice to all affected customers on July 6, 2015. The notice informs consignees of the reason for recall and actions to be taken by the customer/user. On September 15, 2015, Philips plans to issued a mandatory Field Safety Corrective action (FCO72200280) via Certified Return Receipt. This corrective action is the replacement of the affected MCS actuator. For further information, contact your local representative: Technical Support Line: 1-800-722-9377.
- Root cause
- Process control
- Status
- Terminated
- Product code
- IZI
- Quantity affected
- 3158 devices
- Distribution
- Worldwide Distribution - USA (nationwide) including Puerto Rico and the countries of : Canada, Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Bulgaria, Cayman Islands, C
- Date initiated
- 2015-07-06
- Date posted
- 2016-02-16
- Date terminated
- 2017-02-03
- Location
- Andover, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ALLURA XPER FD OR TABLE SERIES; ALLURA XPER FD10 SERIES; ALLURA XPER FD20 SERIES; ALLURA XPER FD BIPLANE SERIES (K130842) | Philips Medical Systems Nederland B.V. | 2013-05-21 |
| ALLURA XPER FD10 (K041949) | Philips Medical Systems North America Co. | 2004-07-30 |
| ALLURA XPER FD20 (K033737) | Philips Medical Systems North America, Inc. | 2003-12-09 |