Reported Jan 19, 2022 · Terminated
Philips Azurion Interventional Fluoroscopic X-ray System with Azurion R2.2 with LUC configuration start-up issue;…
Philips North America LLC
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 North America Llc · 222 Jacobs St · Cambridge, MA · 02141-2289
Is this the product you have?
- Philips Azurion Interventional Fluoroscopic X-ray System with Azurion R2.2 with LUC configuration start-up issue; Azurion R2.2 emergency
- stop recovery issue Model Numbers
722221722228722225722068722226722078722224
- Lot codes and dates
- USModel 722068
- Azurion 7 B20 S/N109
- UDI(01)00884838085367(21)109
- OUSModel:
- S/N UDI722226 Azurion 7 B20 176 (01)00884838099272(21)176; 722228 Azurion 5 M20 3 (01)00884838099234(21)3; 722221 Azurion 3 M12 8 (01)00884838099203(21)8; 722225 Azurion 7 B12 16 (01)00884838099265(21)16; 722225 Azurion 7 B12 73 (01)00884838099265(21)73; 722226 Azurion 7 B20 42 (01)00884838099272(21)42; 722226 Azurion 7 B20 157 (01)00884838099272(21)157; 722224 Azurion 7 M20 293 (01)00884838099258(21)293; 722078 Azurion 7 M12 220 (01)00884838085251(21)220
- Amount recalled
- 10 units (1 US and 9 OUS)
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
- WA
Why it was recalled
(1)Start-up problem: Intermittently at start-up of the system, the communication of the control unit that manages the movement of the stand is not established; (2) Emergency stop recovery problem-warm restart is not executed correctly and movement functionality is not available
This product could cause temporary or reversible health problems — stop using it.
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