Surgical C-arm Systems Recalled for Missing Warning Labels and Tube-Spacers
Philips recalled surgical C-arm systems in US territories without required warning labels and missing the Source-to-Skin Distance Spacer. Facilities should contact Philips for instructions on obtaining missing components.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall involving surgical equipment with missing safety components. Without reported injuries or illnesses, the hazard is theoretical; however, the missing warning label and spacer in a surgical context represent a risk-of-harm scenario justifying a High severity rating.
Plain-English summary
Philips North America is recalling Integris-Allura, Allura Xper, and Azurion surgical C-arm systems that were distributed to Puerto Rico, Guam, and the US Virgin Islands. These systems were delivered without the required warning label and without the Source-to-Skin Distance Spacer (tube-spacer).
The recall addresses the missing warning label and spacer components in the delivered equipment.
This recall affects healthcare facilities and surgical centers in Puerto Rico, Guam, and the US Virgin Islands that received these C-arm systems. The FDA classified this as a Class II recall.
Facilities with affected systems should contact Philips North America for guidance on obtaining replacement components or arranging service.
The recalled product
- Product
- Veradius Unity Mobile Surgery C-arm
- Manufacturer
- Philips North America
- Hazard
- missing-warning-label
- missing-tube-spacer
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Veradius Neo 497 Veradius Neo 607 Veradius Neo 619
Distribution
Distribution scope not specified by the agency.
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