Class IIOngoingZ-2543-2025
Philips Medical Systems Nederland B.V. recalls IntelliSpace Cardiovascular
Software issue that results in the display of outdated information.
Philips Medical System…Sep 17, 2025
Philips Medical Systems Nederland B.V. recalls
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1–5 of 5 recalls
Class IIOngoingZ-1740-2025
Philips Medical Systems Nederland B.V. recalls IntelliSpace Cardiovascular software versions 6.x
An issue was identified with the software when using the Echo Module of ISCV, the issue may result in missing or incomplete information in the report.
Philips Medical System…May 14, 2025
Class IIOngoingZ-1583-2025
Philips Medical Systems Nederland B.V. recalls Zenition 70. The device is to be used in health care facilities both inside and outside…
Philips has become aware of the potential for unintended radiation exposure with Zenition 70 systems with Vascular Extension option and a Wireless Foot Switch.
Philips Medical System…Apr 30, 2025
Class IIOngoingZ-1324-2025
Philips Medical Systems Nederland B.V. recalls Spectral CT on Rails
Multiple problems identified with the software version leading to various scanning and image issues, and unintended device movement.
Philips Medical System…Mar 19, 2025
Class IIOngoingZ-1252-2025
Philips Medical Systems Nederland B.V. recalls Philips IntelliSpace Cardiovascular software
Study data is not able to be archived, copied, or exported with the cardiovascular software version.
Philips Medical System…Mar 12, 2025