Reported Feb 7, 2024 · Ongoing
Philips Azurion system, Interventional fluoroscopic x-ray system. System Product Name - Model Numbers Azurion 3M12…
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 4-6 · Best · N/A
Is this the product you have?
9 of 9 products
| # | Product as published |
|---|---|
| 1 | Philips Azurion system, Interventional fluoroscopic x-ray system. System Product Name - Model Numbers Azurion 3M12 -722063, 722221 |
| 2 | Azurion 3M15 - 722064, 722222 |
| 3 | Azurion 5M12 - 722227 |
| 4 | Azurion 5M20 - 722228 |
| 5 | Azurion 7B12/12 - 722067, 722225 |
| 6 | Azurion 7B20/15 - 722068, 722226 |
| 7 | Azurion 7M12 - 722078, 722223 |
| 8 | Azurion 7M20 - 722079, 722224 |
| 9 | Azurion 3 M15 (China) - 722280 |
- Lot codes and dates
10 of 10 products
Products covered by this recall # Barcodes Product as published 1 008848380852750088483809920300884838101890System Product Name - UDI-DI Azurion 3M12 - 00884838085275, 00884838099203, 00884838101890 2 0088483808528200884838099210Azurion 3M15 - 00884838085282, 00884838099210 3 00884838099227Azurion 5M12 - 00884838099227 4 00884838099234Azurion 5M20 - 00884838099234 5 00884838059290008848380647750088483808535000884838099265Azurion 7B12/12 - 00884838059290, 00884838064775, 00884838085350, 00884838099265 6 0088483805920700884838064775008848380853670088483809927200884838101883Azurion 7B20/15 - 00884838059207, 00884838064775, 00884838085367, 00884838099272, 00884838101883 7 008848380852510088483809924100884838101890Azurion 7M12 - 00884838085251, 00884838099241, 00884838101890 8 0088483805918400884838059191008848380592070088483805922100884838059290008848380647750088483808526800884838086777008848380992580088483810188300884838101890Azurion 7M20 - 00884838059184, 00884838059191, 00884838059207, 00884838059221, 00884838059290, 00884838064775, 00884838085268, 00884838086777, 00884838099258, 00884838101883, 00884838101890 9 008848380852820088483809921000884838103276Azurion 3 M15 (China) - 00884838085282, 00884838099210, 00884838103276 10 Software Version Numbers R1.0, R1.1, R1.2, R2.0, R2.1, and R2.2 - Amount recalled
- 1,799 US; 5,747 OUS
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
System may exhibit a loss of imaging functionality and data due to an issue which can cause the system to continuously restart. If the issue occurs during a procedure, there may be a delay and/or abortion of the procedure.
This product could cause temporary or reversible health problems — stop using it.
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