FDA Medical Device Recalls (openFDA)
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Philips Allura Xper, Allura Centron, Allura CV, Azurion, UNIQ Clarity, and MultiDiagnost-Eleva systems
- Recall number
- Z-2587-2023
- Recalling firm
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Product
- Philips Allura Xper, Allura Centron, Allura CV, Azurion, UNIQ Clarity, and MultiDiagnost-Eleva systems
- Status
- Open, Classified
- Initiated
- 2023-08-15
- Posted
- 2023-09-14
- Terminated
- not on file
- Reason
- A damaged foot switch may cause instances where no or only intermittent x-ray radiation initiation is possible.
- Root cause
- Device Design
- Action
- US customers were notified via certified mail via USPS. OUS customers were notified through the Philips Markets Organizations. Philips is issuing two Urgent Medical Device Correction letters, one for Allura and Azurion customers and another one for MultiDiagnost Eleva Customers. Additionally, an IFU addendum will be provided to customers that includes instructions on how to handle the footswitch cable. For Allura and Azurion customers an updated preventative maintenance manual update is also being provided. Philips will contact customers to schedule a visit to inspect the foot switch and to provide an IFU Addendum.
- Quantity
- 19,115 systems
- Distribution
- Worldwide distribution
- Lot, serial or model codes
- Models: 708032, 708034, 708036, 708037, 708038, 722001, 722002, 722003, 722005, 722006, 722008, 722010, 722011, 722012, 722013, 722015, 722019, 722020, 722022, 722023, 722025, 722026, 722027, 722028, 722029, 722031, 722033, 722035, 722038, 722039, 722058, 722059, 722063, 722064, 722065, 722066, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228, 722280, 722400 No UDI-DI information for foot switch component.
- 510(k) numbers
- ["K050151","K162859","K163715","K200917"]
- PMA numbers
- not on file
- Product code
- OWB
- Firm FEI
- 3002807880
- Firm city
- Best
- Firm state
- not on file
- Firm country
- Netherlands
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28