FDA Medical Device Recalls (openFDA)
Philips Medical Systems Nederland B.V.: Allura Xper series
- Recall number
- Z-2402-2023
- Recalling firm
- Philips Medical Systems Nederland B.V.
- Product
- Allura Xper series
- Status
- Open, Classified
- Initiated
- 2023-07-19
- Posted
- 2023-09-07
- Terminated
- not on file
- Reason
- A foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation
- Root cause
- Radiation Control for Health and Safety Act
- Action
- Philips will send a customer notification to the existing users of the affected systems to alert them of the issue and provide actions that should be taken by the customer/user in order to prevent risks to patients. Philips will contact customers to schedule a visit to inspect the foot switch and provide an addendum to the Instructions for Use (IFU) of the system detailing the appropriate cleaning and maintenance instructions. (Philips reference 2023-IGT-BST-011).
- Quantity
- 5432 systems in total
- Distribution
- US Nationwide Distribution
- Lot, serial or model codes
- Allura Xper series
- 510(k) numbers
- ["K162859"]
- PMA numbers
- not on file
- Product code
- OWB
- Firm FEI
- 3000976525
- Firm city
- Eindhoven
- 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