Philips Azurion Rystem recall
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalled Philips Azurion Rystem on August 19, 2026 because of two software related issues affecting Azurion R2.2.10 Systems: 1) Potential image quality degradation that may lead to delay of therapy, procedural complications and/or inappropriate treatment and 2) Potential loss of geometry movements that may lead to delay of therapy and procedural complications. It was sold in Worldwide.
Why it was recalled
Two software related issues affecting Azurion R2.2.10 Systems: 1) Potential image quality degradation that may lead to delay of therapy, procedural complications and/or inappropriate treatment and 2) Potential loss of geometry movements that may lead to delay of therapy and procedural complications
What's recalled
Philips Azurion Rystem, Model Numbers: 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222,722223, 722224, 722225, 722226, 722227, 722228, 722280*, 722281*, and 722282* (*These models are distributed only in China), with Software Version Number R2.2.10 and R2.1.10* (*This software version is distributed only in China); Interventional Fluoroscopic X-Ray System
Quantity: 10872 units
What to do
Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.
Read the official FDA noticeDetails
- Company
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V., Best
- Date
- Severity
- Class II
the product could cause temporary or reversible health problems. - Where sold
- Worldwide
- Status
- Ongoing
- Recall number
- Z-2931-2026
- Source
- U.S. Food and Drug Administration
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