Reported Apr 8, 2026 · Ongoing
Azurion 5 M20; System Code: (1)722228, (2)722232, (3) 722281 (OUS only);
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 M20
- System Code
(1)722228(2)722232(3) 722281 (OUS only)
- Lot codes and dates
- (1)
- System Code722228
- UDI00884838099234
- System Serial Number
550 of 550 codes
67524496786791036641104033284813731492134553761515918231180612042735387650215013239953321117473887617618619128522326002325621771814818915379801572418726642431
- System Code722232
- UDI00884838116757
- System Serial Number
90 of 90 codes
533341064913891295963623108424846766606110439781131181191392250756313013289866936739444122123717211093168117720757582601151482
- System Code722281
- UDI00884838110564
- System Serial Number
282 of 282 codes
125176233296742845581372113527839017918118228228635735835910913693153247272829976140603413101922751271082542552420129343295215669848235378145336115348120171265217
- Amount recalled
- 920 units (168 US, 752 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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