Recall Z-0461-2026— Philips Medical Systems DMC GmbH

Name: FDA recall Z-0461-2026
Creator: U.S. Food and Drug Administration
Published: 2025-10-01

Class II · Ongoing

Class II FDA medical device recall by Philips Medical Systems DMC GmbH, initiated 2025-10-01. It names one FDA 510(k) clearance: K233945. Product: ProxiDiagnost N90; Model Number: 706110;. Reason: Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2024 through June 2025 may be difficult to move vertically (i.e. additional force/physical exertion required for manual movement) due to potential manufacturing issues..

Recalling firm: Philips Medical Systems DMC GmbH
Classification: Class II
Status: Ongoing
Initiated: 2025-10-01
Firm location: Hamburg, Germany

510(k) clearances named in this recall

1 on FDA's record

K233945 — ProxiDiagnost N90 / Precision CRF (706110, 706400)Philips Medical Systems Dmc GmbH·cleared 2024-01-11

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

ProxiDiagnost N90; Model Number: 706110;

Reason for recall

Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2024 through June 2025 may be difficult to move vertically (i.e. additional force/physical exertion required for manual movement) due to potential manufacturing issues.

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