Home / Recalls / Philips Medical Systems Nederland B.V. / Z-1252-2025

Z-1252-2025 Class II Ongoing

Recalled by Philips Medical Systems Nederland B.V. — Eindhoven

Recall Details

Product Type
Devices
Report Date
March 12, 2025
Initiation Date
April 4, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
139

Product Description

Philips IntelliSpace Cardiovascular software, Model 830089.

Reason for Recall

Study data is not able to be archived, copied, or exported with the cardiovascular software version.

Distribution Pattern

US Nationwide distribution in the states of AK, AL, AZ, CA, CT, FL, GA, IA, IN, KY, MA, MI, MN, NC, NE, NY, OH, OR, TN, TX, VA, and WI. There was government distribution but no military distribution.

Code Information

Software version 7.0.0.0, UDI (01)00884838115378(11)221214(10)7.0.0.0.

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)