Recall Z-0271-2024— Philips North America Llc

Name: FDA recall Z-0271-2024
Creator: U.S. Food and Drug Administration
Published: 2023-09-21

Class II · Ongoing

Class II FDA medical device recall by Philips North America Llc, initiated 2023-09-21. It names one FDA 510(k) clearance: K203087. Product: CombiDiagnost R90, Radiography and Fluoroscopy (R/F) system. Reason: Potential for units suspended on the ceiling to fail and fall..

Recalling firm: Philips North America Llc
Classification: Class II
Status: Ongoing
Initiated: 2023-09-21
Firm location: Cambridge, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K203087 — CombiDiagnost R90Philips Medical Systems Dmc GmbH·cleared 2020-12-03

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

CombiDiagnost R90, Radiography and Fluoroscopy (R/F) system

Reason for recall

Potential for units suspended on the ceiling to fail and fall.

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