X-ray imaging systems recalled for missing warning label and spacer
Philips X-ray imaging systems delivered to Puerto Rico are missing warning labels and Source-to-Skin Distance Spacers. These missing safety components could affect user safety during imaging procedures.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: FDA Class II recall for missing safety-critical component (Source-to-Skin Distance Spacer) and warning label on diagnostic imaging equipment. Although no injuries are reported, the missing safety components constitute a risk-of-harm situation on medical devices.
Plain-English summary
Philips North America is recalling Allura Xper and related imaging systems (Integris-Allura, Azurion) that were delivered to Puerto Rico. These X-ray imaging systems are missing critical safety components and documentation.
The affected systems lack warning labels and are missing the Source-to-Skin Distance Spacer (Tube-spacer). This spacer is a safety component that helps control radiation exposure during imaging procedures. The missing warning label prevents users from receiving important safety instructions.
Affected facilities in Puerto Rico should immediately contact Philips North America. Users should discontinue use of affected systems until the missing components are installed and the warning labels are applied. Facilities should verify that their systems are on the recalled model list and contact the manufacturer for replacement components.
The recalled product
- Product
- Allura Xper IGTS Fixed Systems
- Manufacturer
- Philips North America
Distribution
Part of a larger recall action
This product is one of 6 recalled by Philips North America under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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