Home / Recalls / Philips Medical Systems Nederland B.V. / Z-2403-2023

Z-2403-2023 Class II Ongoing

Recalled by Philips Medical Systems Nederland B.V. — Eindhoven, N/A

Recall Details

Product Type
Devices
Report Date
September 13, 2023
Initiation Date
July 19, 2023
Termination Date
N/A
Voluntary/Mandated
FDA Mandated
Product Quantity
5432 systems in total

Product Description

Azurion

Reason for Recall

A foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation

Distribution Pattern

US Nationwide Distribution

Code Information

Azurion series

Other recalls by Philips Medical Systems Nederland B.V.

  • Z-1805-2026 Class II — Philips AneurysmFlow. Model Number: 001015. AneurysmFlow is a software medic (March 19, 2026)
  • Z-1692-2026 Class II — Vue Motion V12. Product Number: 1017979. (March 5, 2026)
  • Z-1678-2026 Class II — Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only (March 3, 2026)
  • Z-1672-2026 Class II — Allura Xper FD20/15 OR Table; System Code: 722059; (March 3, 2026)
  • Z-1666-2026 Class II — ALLURA Xper FD20 Biplane OR Table; System Code: (1) 722020, (2)722025; (March 3, 2026)
  • Z-1664-2026 Class II — ALLURA Xper FD20 Biplane; System Code: (1) 722008, (2)722013; (March 3, 2026)
  • Z-1668-2026 Class II — Allura Xper FD20/10; System Code: 722029; (March 3, 2026)
  • Z-1660-2026 Class II — ALLURA Xper FD10F; System Code: 722002; (March 3, 2026)
  • Z-1673-2026 Class II — Azurion 3 M12; System Code: (1)722063, (2)722221, (3)722229; (March 3, 2026)
  • Z-1679-2026 Class II — Azurion 5 M12; System Code: (1)722227, (2)722231; (March 3, 2026)