Home / Recalls / PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. / Z-1897-2024

Z-1897-2024 Class II Ongoing

Recalled by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Best

Recall Details

Product Type
Devices
Report Date
June 5, 2024
Initiation Date
May 16, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1 unit (OUS)

Product Description

Philips Allura Xper FD20 Biplane system with an ADN7NT patient table. Model Number: 722013, Software Version Number 8.1.100.

Reason for Recall

When Software upgrade 8.1.100 is installed on an Allura Xper with an AD7NT (non tilt) table, the pivot brake does not engage. This issue may cause unexpected movements of the table.

Distribution Pattern

Domestic: OK International: India, Spain, U.A.E.

Code Information

Product number: 722013, UDI/DI: 00884838059061; Serial Number: 232.

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  • 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)