Reported Jun 7, 2023 · Ongoing
Philips Azurion System with software versions
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 · N/A
Is this the product you have?
Philips Azurion System with software versions
8 of 8 products
| # | Product as published |
|---|---|
| 1 | R2.2.O, R2.2.1, R2.2.3, R2.2.5 and R2.2.6. Models/Model Number: (1) Azurion 3M12: 722063, 722221 |
| 2 | (2) Azurion 3M15: 722064, 722222 |
| 3 | (3) Azurion SM12: 722227 |
| 4 | (4) Azurion SM20: 722228 |
| 5 | (5) Azurion 7B12/12: 722067, 722225 |
| 6 | (6) Azurion 7820/15: 722068, 722226 |
| 7 | (7) Azurion 7M12: 722078, 722223 |
| 8 | (8) Azurion 7M20 : 722079, 722224 |
- Lot codes and dates
8 of 8 products
Products covered by this recall # Barcodes Product as published 1 0088483808527500884838099203System product name Model number UDI (1)Azurion 3M12: 722063 (01)00884838085275(21) 722221 (01)00884838099203(21) 2 0088483808528200884838099210(2) Azurion 3M15: 722064 (01)00884838085282(21) 722222 (01)00884838099210(21) 3 00884838099227(3) Azurion SM12: 722227 (01)00884838099227(21) 4 00884838099234(4) Azurion SM20: 722228 (01)00884838099234(21) 5 0088483808535000884838099265(5) Azurion 7B12/12: 722067 (01)00884838085350(21) 722225 (01)00884838099265(21) 6 0088483808536700884838099272(6) Azurion 7820/15: 722068 (01)00884838085367(21) 722226 (01)00884838099272(21) 7 0088483808525100884838099241(7) Azurion 7M12: 722078 (01)00884838085251(21) 722223 (01)00884838099241(21) 8 0088483808526800884838099258(8) Azurion 7M20: 722079 (01)00884838085268(21) 722224 (01)00884838099258(21), Software: R2.2.O, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 - Amount recalled
- USA: 1063 R.O.W. 2136
Where it was sold
- Nationwide
- PR
Why it was recalled
Potential Loss of X-ray-When the full disk capacity is reached, X-Ray functionality will cease to be available there will be a sudden interruption of the procedure
This product could cause temporary or reversible health problems — stop using it.
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