Philips North America Veradius Unity Mobile Surgery C-arm Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Veradius Unity Mobile Surgery C-arm
Brand
Philips North America
Lot Codes / Batch Numbers
Veradius Neo 497 Veradius Neo 607 Veradius Neo 619
Products Sold
Veradius Neo 497 Veradius Neo 607 Veradius Neo 619
Philips North America is recalling Veradius Unity Mobile Surgery C-arm due to 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. Based on FDA medical device recall database.
Summary derived from FDA notice
The following details were not provided by the FDA: corrective action details.
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Healthcare providers and patients should stop using the device and contact the manufacturer for further instructions. Report problems to FDA MedWatch.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026