Recall Z-1088-2024— PHILIPS MEDICAL SYSTEMS

Name: FDA recall Z-1088-2024
Creator: U.S. Food and Drug Administration
Published: 2022-02-11

Class II · Ongoing

Class II FDA medical device recall by PHILIPS MEDICAL SYSTEMS, initiated 2022-02-11. It names one FDA 510(k) clearance: K203087. Product: CombiDiagnost R90 1.1 (709031). Reason: While performing a fluoroscopy examination, there is a potential that the Radio Fluoroscopy (RF) viewer will also display a previous patient's radiography images. If the issue occurs, there will be differences in image content, image format and image size..

Recalling firm: PHILIPS MEDICAL SYSTEMS
Classification: Class II
Status: Ongoing
Initiated: 2022-02-11
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 1.1 (709031)

Reason for recall

While performing a fluoroscopy examination, there is a potential that the Radio Fluoroscopy (RF) viewer will also display a previous patient's radiography images. If the issue occurs, there will be differences in image content, image format and image size.

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