Reported Apr 8, 2026 · Ongoing
Azurion 3 M15; System Code: (1)722064, (2)722222, (3)722230, (4)722280 (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 3 M15
- System Code
(1)722064(2)722222(3)722230(4)722280 (OUS Only)
- Lot codes and dates
- (1)
- System Code722064
- UDI00884838085282
- System Serial Number
337 of 337 codes
2092382012582602613142292912702672183355136116116216929713147919026817322025629050242541289303130157602632642532542572803734179277102467461137461018451057849345180185266
- System Code722222
- UDI00884838099210
- System Serial Number
250 of 250 codes
33211125425625726525510099310691222615192317554518722335811211336712035626237318152364146246269753043161742303073203363383393403433443453463623081822756312368172137302
- System Code722230
- UDI00884838116733
- System Serial Number
40222105045192023253041677451528603896263575854553927521312168(4)
- System Code722280
- UDI00884838103276
- System Serial Number
179 of 179 codes
571614317922924965762321131671658012815814919444100164240246661351759911234791304852141131142143144189378322313987612592189018810523301329610717111821174220147
- Amount recalled
- 798 units (42 US, 756 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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