Philips recalls Azurion R3.0 interventional fluoroscopy systems (model 722234) shipped between July 2024 and June 2025 due to missing SSD spacer, which could fail FDA safety requirements for source-skin distance.
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 SSD spacer is necessary to meet the FDA minimum source-skin distance requirement of 38 cm for standard fluoroscopy applications.
Philips is recalling Azurion R3.0 interventional fluoroscopy systems (model 722234) that were shipped without the required SSD spacer between July 2024 and June 2025. This spacer is critical for meeting FDA safety standards for X-ray source-skin distance, and its absence could lead to potential safety issues during medical procedures.
The missing SSD spacer could fail to maintain the required 38 cm source-skin distance for standard fluoroscopy applications. This may not cause immediate harm but could lead to safety issues if the system is used without the spacer, potentially violating FDA safety standards.
Healthcare facilities using Philips Azurion R3.0 systems with model number 722234 (Azurion 7 M20) shipped between July 2024 and June 2025 are most at risk. Medical staff and patients using these systems may face safety concerns if the missing spacer is not addressed.
Check for the model number 722234 on the system, which is labeled as 'Azurion 7 M20'. The recall covers systems shipped by Philips North America between July 2024 and June 2025.
Inspect the FlexArm stand for the presence of the Source-to-Skin Distance (SSD) spacer, which was shipped without it between July 2024 and June 2025.
Philips shipped Azurion R3.0 systems with model number 722234 without the required SSD spacer between July 2024 and June 2025.
Check if your system has the missing SSD spacer; if so, contact Philips for guidance on the necessary steps to address the issue.
The missing spacer could lead to safety issues by failing to meet FDA source-skin distance requirements, but the remedy does not specify immediate action beyond checking for the spacer.
We’ve drafted a message you can send Philips to request your refund or repair — edit it as you like.
Subject: Recall Z-0597-2026 — Philips Philips Hello, I own a Philips that is covered by recall Z-0597-2026 from Philips. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
