Fluoroscopy systems recalled after shipping without the source-to-skin distance spacer
Philips is recalling 110 Azurion R3.0 systems shipped with a FlexArm stand but without the Source-to-Skin Distance spacer needed to meet the FDA minimum 38 cm requirement.
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: Scored 3 under the risk-of-harm criterion: the systems shipped without a component the firm states is necessary to meet an FDA safety requirement, and no injuries are reported.
Plain-English summary
The Philips Azurion R3.0, model number 722234, commercial name Azurion 7 M20, an interventional fluoroscopic X-ray system, is being recalled.
Between July 2024 and June 2025, Philips Azurion R3.0 systems with a FlexArm stand were shipped without the Source-to-Skin Distance (SSD) spacer. The firm states the SSD spacer is necessary to meet the FDA minimum source-skin distance requirement of 38 cm for standard fluoroscopy applications.
The record lists 110 units, identified by Philips reference C&R 2025-IGT-BST-016. Distribution was in the United States. The FDA has classified the action as Class II.
A system missing a component required to meet a safety requirement should not be used until the firm's instructions are followed. The enforcement record reports no injuries.
The recalled product
- Product
- Azurion R3.0. Model Number 722234. Commercial Name: Azurion 7 M20. INTERVENTIONAL FLUOROSCOPIC XRAY SYSTEM
- Manufacturer
- Philips North America
- Affected units
- 110
Distribution
Distribution scope not specified by the agency.
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