Recall Z-2543-2025— Philips Medical Systems Nederland B.V.

Name: FDA recall Z-2543-2025
Creator: U.S. Food and Drug Administration
Published: 2025-08-08

Class II · Ongoing

Class II FDA medical device recall by Philips Medical Systems Nederland B.V., initiated 2025-08-08. It names one FDA 510(k) clearance: K153022. Product: IntelliSpace Cardiovascular, Software 8.0.0.4.. Reason: Software issue that results in the display of outdated information..

Recalling firm: Philips Medical Systems Nederland B.V.
Classification: Class II
Status: Ongoing
Initiated: 2025-08-08
Firm location: Eindhoven, N/A, Netherlands

510(k) clearances named in this recall

1 on FDA's record

K153022 — Philips IntelliSpace CardiovascularPhilips Medical Systems Nethrlands BV·cleared 2015-11-18

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

IntelliSpace Cardiovascular, Software 8.0.0.4.

Reason for recall

Software issue that results in the display of outdated information.

Data sourced from openFDA. This site is unofficial and independent of the FDA.