Azurion medical imaging systems recalled for missing safety spacer and warning label
Philips Azurion IGTS Fixed Systems delivered to U.S. territories lack required safety components. The Source-to-Skin Distance Spacer and warning label are missing from affected units.
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: FDA Class II recall involving missing safety components on medical imaging equipment with no reported illnesses or injuries. The missing spacer and warning label present a theoretical risk of improper use rather than confirmed harm.
Plain-English summary
Philips North America has recalled Azurion IGTS Fixed Systems and related medical imaging equipment due to manufacturing defects. Certain units delivered to Puerto Rico, Guam, and the Virgin Islands were manufactured without a required warning label and without the Source-to-Skin Distance Spacer (tube-spacer), a critical safety component.
The missing spacer and warning label create a potential safety hazard. The Source-to-Skin Distance Spacer is designed to ensure proper operating parameters for the imaging system. Without these components, facilities cannot maintain proper safety protocols.
Healthcare facilities in Puerto Rico, Guam, and the Virgin Islands that have received Azurion systems should contact Philips North America immediately to verify whether their equipment includes both the warning label and the Source-to-Skin Distance Spacer. Affected model codes include Azurion 7 M12 465, M20 702, M20 942, M20 948, and M20 503.
The recalled product
- Product
- Azurion IGTS Fixed Systems
- Manufacturer
- Philips North America
- Category
- Medical Device — Medical Imaging
- Hazard
- missing-safety-component
- missing-warning-label
Distribution
Distribution scope not specified by the agency.
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