PlainRecalls
FDA Devices Moderate Class II Ongoing

CombiDiagnost R90 1.1 (709031)

Reported: February 21, 2024 Initiated: February 11, 2022 #Z-1088-2024

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.

Details

Recalling Firm
PHILIPS MEDICAL SYSTEMS
Units Affected
130 units
Distribution
US Nationwide distribution in the states of CA, FL, GA, IL, IN, KS, MD, ME, MI, MN, NC, NJ, NY, TX, VA, WA.
Location
Cambridge, MA

Frequently Asked Questions

What product was recalled?
CombiDiagnost R90 1.1 (709031). Recalled by PHILIPS MEDICAL SYSTEMS. Units affected: 130 units.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on February 21, 2024. Severity: Moderate. Recall number: Z-1088-2024.