Reported Apr 8, 2026 · Ongoing
Azurion 5 M12; System Code: (1)722227, (2)722231;
Philips Medical Systems Nederland B.v.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Veenpluis 6 · Best · N/A
Is this the product you have?
- Azurion 5 M12
- System Code
(1)722227(2)722231
- Lot codes and dates
- (1)
- System Code722227
- UDI00884838099227
- System Serial Number
291 of 291 codes
265135882762642716323836023127159197149545623019215625098311288124373201792701515324624584382829170303383241083051681723563466223625313339104321591091011915599
- System Code722231
- UDI00884838099258
- System Serial Number
135249504168215367473171825728793943469612680678456012637314485628667581452019512927113562543392123259
- Amount recalled
- 345 units (10 US, 335 OUS)
This recall covers 23 products
The agency filed one notice per product. You are reading one of them; the other 22 are below.
10 more are in the archive.
Where it was sold
- Nationwide
- GA
Why it was recalled
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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