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.
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 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
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.
See all 6 products in this recall →Related recalls
Same manufacturer · Philips North America
See all →- ModeratePhilips Recalls SmartPath MRI Software Due to Incorrect DTI Export Data
FDA (Devices) · 2026-10-07
- ModeratePhilips SmartPath to MR 7700 Recalled for Incorrect DTI Export Data
FDA (Devices) · 2026-10-07
- ModeratePhilips MR 5300 Recalled for Incorrect Diffusion Tensor Imaging Data
FDA (Devices) · 2026-10-07
- ModeratePhilips Ingenia Ambition MRI Systems Recalled for Incorrect DTI Data Exports
FDA (Devices) · 2026-10-07
- ModeratePhilips MR 7700 Software Upgrade Recalled for Incorrect DTI Data
FDA (Devices) · 2026-10-07
Same hazard · missing safety component
See all →- HighBiomarC EX Fiducial Marker System recalled for missing MRI safety component
FDA (Devices) · 2024-09-25
- Moderate
- HighSurgical C-arm systems recalled for missing warning label and spacer
FDA (Devices) · 2023-11-15
- HighX-ray imaging systems recalled for missing warning label and spacer
FDA (Devices) · 2023-11-15
- HighBeckman Coulter Power Processor 3K Recalled for Missing Splash Guard
FDA (Devices) · 2021-10-20
Similar recalls
- HighFluoroscopy systems recalled after shipping without the source-to-skin distance spacer
FDA (Devices) · 2025-12-17
- HighAzurion imaging systems recalled over two software issues affecting imaging
FDA (Devices) · 2026-01-28
- ModeratePhilips Medical Imaging Systems Recalled for Measurement Export Error
FDA (Devices) · 2017-12-27
- ModeratePhilips Recalls Azurion X-ray Systems Due to Software Defect
FDA (Devices) · 2019-08-07
- HighAzurion imaging systems recalled for stuck foot switch causing unintended radiation
FDA (Devices) · 2023-09-13
- HighPhilips Azurion 3 Surgical Imaging System Recalled for Power Failure Risk
FDA (Devices) · 2024-02-28