PlainRecalls
FDA Devices Moderate Class II Ongoing

Veradius Unity Mobile Surgery C-arm

Reported: November 15, 2023 Initiated: October 4, 2023 #Z-0230-2024

Product Description

Veradius Unity Mobile Surgery C-arm

Reason for Recall

Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion systems that have been delivered to Puerto Rico without a warning label and the Source-to-Skin Distance Spacer (Tube-spacer) is missing.

Details

Recalling Firm
Philips North America
Distribution
United States Territories of Puerto Rico, Guam, and Virgin Islands
Location
Cambridge, MA

Frequently Asked Questions

What product was recalled?
Veradius Unity Mobile Surgery C-arm. Recalled by Philips North America.
Why was this product recalled?
Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion systems that have been delivered to Puerto Rico without a warning label and the Source-to-Skin Distance Spacer (Tube-spacer) is missing.
Which agency issued this recall?
This recall was issued by the FDA Devices on November 15, 2023. Severity: Moderate. Recall number: Z-0230-2024.