Recall Z-1740-2025— Philips Medical Systems Nederland B.V.

Name: FDA recall Z-1740-2025
Creator: U.S. Food and Drug Administration
Published: 2025-04-07

Class II · Ongoing

Class II FDA medical device recall by Philips Medical Systems Nederland B.V., initiated 2025-04-07. It names one FDA 510(k) clearance: K153022. Product: IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x; Model Number: 830089.. Reason: 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..

Recalling firm: Philips Medical Systems Nederland B.V.
Classification: Class II
Status: Ongoing
Initiated: 2025-04-07
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 versions 6.x, 7.x, and 8.x; Model Number: 830089.

Reason for recall

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.

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