Wireless Footswtich used with the following Philips Allura Xper and Azurion Interventional Fluoroscopic X-ray System . M
FDA device recall Z-0476-2022 · posted 2022-01-10 · Open, Classified
Recall details
- Recalling firm
- Philips North America Llc
- Reason for recall
- Wireless foot switch connection issues causing interruption of Fluoroscopy and exposure
- Action taken
- Philips notified customers via an Urgent Medical Device Correction letter on October 29th, 2021 via Certified Mail. Letters outside of the U.S.A. will be distributed through the Philips Markets Organizations. Letter states reason for recall, health risk and actions that should be taken by the user in order to prevent risks for patients or users " Ensure that the wired foot switch is always connected to the system. The wired foot switch is always provided with the Allura Xper and the Azurion systems. " Immediately start using the wired foot switch in case the wireless foot switch loses connection. " Circulate this notice to all users of this device so that they are aware of the issue. " Place this Medical Device Correction with the documentation of the Philips Allura Xper or Azurion system. " Return the attached reply form to Philips to confirm that: the Allura Xper and Azuarion system wired foot switch is connected to the system the users of the system have reviewed and understood this Medical Device Correction. S. The actions planned by Philips IGT Systems to correct the problem You will be contacted by your local Philips representative as soon as this solution is available. If you need any further information or support concerningthis issue, please contact your local Philips representative. Technical Support Line: 1-800-722-9377
- Root cause
- Device Design
- Status
- Open, Classified
- Product code
- OWB
- Quantity affected
- 1971 Total; USA: 681 systems R.O.W.: 1,290 systems
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Australia, Austria, Bangladesh, Belgium, Chile, China, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland
- Date initiated
- 2021-10-29
- Date posted
- 2022-01-10
- Location
- Cambridge, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Azurion R2.1 (K200917) | Philips Medical Systems Nederland B.V. | 2020-05-01 |
| Allura Xper FD series and Allura Xper OR Table series (K161563) | Philips Medical Systems Nederland B.V. | 2016-07-29 |