Philips recalls Azurion interventional fluoroscopy systems with software version 1.2 due to potential radiation emissions too low for diagnostic images. Affected units may need software update.
Philips has discovered through customer complaints and internal testing an intermittent electronic product defect in accordance with 21 CFR 1003.2(b)(1). When performing Cine runs, the Azurion's automatic exposure control software may set technique factors that result in radiation emissions too low to obtain useful diagnostic images.
Philips is recalling Azurion interventional fluoroscopy systems with software version 1.2 because the automatic exposure control may produce radiation levels too low to create useful medical images. This could lead to poor diagnostic results during procedures.
The automatic exposure control software may set technique factors that result in radiation emissions too low to obtain useful diagnostic images during cine runs. This could cause images to be too dark or blurry for proper diagnosis.
Medical professionals using Philips Azurion systems with software version 1.2. Patients undergoing procedures with these systems may be at risk of inaccurate imaging results.
Check if your Azurion interventional fluoroscopy system has software version 1.2 (R1.2). The system may have a label indicating the software version on the device or in the user manual.
Look for software version 1.2 (R1.2) on the device or in the user manual.
No immediate danger to users, but poor imaging could affect medical procedures.
Check if your Azurion system has software version 1.2 (R1.2) on the device or in the user manual.
Contact Philips for a software update to fix the issue.
We’ve drafted a message you can send Philips Medical Systems to request your refund or repair — edit it as you like.
Subject: Recall Z-1997-2019 — Philips Medical Systems Philips Medical Systems Hello, I own a Philips Medical Systems that is covered by recall Z-1997-2019 from Philips Medical Systems. 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.
