Recall Z-0288-2027— Philips North America

Name: FDA recall Z-0288-2027
Creator: U.S. Food and Drug Administration
Published: 2026-09-18

Class II · Ongoing

Class II FDA medical device recall by Philips North America, initiated 2026-09-18. It names one FDA 510(k) clearance: K233678. Product: Model Number: 712010.. Reason: Potential for the device to fail immediately after an exposure, causing the system to remain stationary..

Recalling firm: Philips North America
Classification: Class II
Status: Ongoing
Initiated: 2026-09-18
Firm location: Cambridge, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K233678 — Radiography 7000 MPhilips Medical Systems Dmc GmbH·cleared 2024-02-14

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

Model Number: 712010.

Reason for recall

Potential for the device to fail immediately after an exposure, causing the system to remain stationary.

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