Home / Recalls / PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. / Z-2716-2024

Z-2716-2024 Class II Ongoing

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

Recall Details

Product Type
Devices
Report Date
August 28, 2024
Initiation Date
August 8, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
6 units

Product Description

Philips Allura Xper systems (R8.1 with Poly-G Stand) Interventional Fluoroscopic X-Ray System, Model Numbers 722010, 722012, 722013

Reason for Recall

A half-threaded bolt was included in the LTE kits instead of the correct full-threaded bolt.

Distribution Pattern

Worldwide - US Nationwide distribution in the states of IL and OR. The countries of Hungary, Ireland, Poland, UK.

Code Information

Serial Numbers: 111 138 467 817 2928 269

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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)