Recall Z-0923-2017
Philips Electronics North America Corporation · initiated December 1, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Allura Xper FD10 722026 is intended for: Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and Electro Physiology(EP).
Codes / lots: 783
Reason for recall
Due to a production error, screws were not tightened to specified torque. These screws may come loose from the C-arm shaft causing the C-arm to rotate uncontrolled.
FDA-determined cause: Process control
Action taken
Customers were notified of the recall via letter sent on 12/1/16. The letter explains the issue and the action that Philips plans to take.
Details
- Recall number
- Z-0923-2017
- Initiated
- December 1, 2016
- Posted by FDA
- January 20, 2017
- Terminated
- August 10, 2017
- Product code
- IZI – System, X-Ray, Angiographic
- Quantity
- 1
- Distribution
- US: WA OUS: China, Spain, Korea, Republic of, Germany
- Recalling firm
- Philips Electronics North America Corporation, Andover, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0922-2017 Class II | Allura Xper FD20 722012 is intended for: Cardiovascular and vascular X-ray imaging…Due to a production error, screws were not tightened to specified torque. These screws may come loose from… | 12/01/2016Terminated |
| Z-0924-2017 Class II | Allura Xper FD20 R8.2 722028 is intended for: Cardiovascular and vascular X-ray imaging…Due to a production error, screws were not tightened to specified torque. These screws may come loose from… | 12/01/2016Terminated |
| Z-0925-2017 Class II | Allura Xper FD20/15 R8.2 722058 is intended for: Cardiovascular and vascular X-ray…Due to a production error, screws were not tightened to specified torque. These screws may come loose from… | 12/01/2016Terminated |