Philips Azurion recall
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalled Philips Azurion on August 19, 2026 because of two software related issues: 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 distribution..
Why it was recalled
Two software related issues: 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, Model Numbers: 722229, 722230, 722231, 722232, 722233, 722234, 722235, and 722236, with Software Version Numbers: R3.0 and R3.1; Interventional fluoroscopic x-ray system
Quantity: 2016 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 distribution.
- Status
- Ongoing
- Recall number
- Z-2932-2026
- Source
- U.S. Food and Drug Administration
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