United StatesInterventional fluoroscopic X‑ray systems sold as Philips Allura (including multiple Allura Xper FD10/FD20 variants and Allura Centron) and Philips Azurion (3/5/7 series) are affected; they can be recognised by the system descriptions and the listed model numbers (examples include 722003, 722010, 722033, 722063, 722227, 722400). They were recalled because of a hazard that may cause loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized hard disk drives.
What's being recalled
Philips Allura under the following System Descriptions and corresponding model numbers: 1. Allura Xper FD10; Model Numbers: 722003, 722010, 722026. 2. Allura Xper FD10 OR Table; Model Number: 722033. 3. Allura Xper FD10/10; Model Numbers: 722005, 722011, 722027. 4. Allura Xper FD10C; Model Number: 722001. 5. Allura Xper FD20; Model Numbers: 722006, 722012, 722028. 6. Allura Xper FD20 Biplane; Model Numbers: 722008, 722013. 7. Allura Xper FD20 Biplane OR Table; Model Number: 722025. 8. Allura Xper FD20 OR Table; Model Numbers: 722015, 722023, 722035. 9. Allura Xper FD20/10; Model Number: 722029. 10. Allura Xper FD20/15; Model Number: 722058. 11. Allura Xper FD20/15 OR Table; Model Number…
Philips Azurion under the following System Descriptions and corresponding model numbers: 1. Azurion 3 M12; Model Numbers: 722063, 722221. 2. Azurion 3 M15; Model Numbers: 722064, 722222, 722280. 3. Azurion 5 M12; Model Number: 722227. 4. Azurion 5 M20; Model Numbers: 722228, 722281. 5. Azurion 7 B12; Model Numbers: 722067, 722225. 6. Azurion 7 B20; Model Numbers: 722068, 722226. 7. Azurion 7 M12; Model Numbers: 722078, 722223. 8. Azurion 7 M20; Model Numbers: 722079, 722224, 722282. Interventional Fluoroscopic X-Ray System.
Philips Allura, Cardio Vascular-Allura Centron. Model Number: 722400. Interventional Fluoroscopic X-Ray System.
Recalling firm: Philips Medical Systems Nederland B.V., Best, Netherlands.
How to identify it
1. Allura Xper FD10; Model Numbers (UDI Numbers): 722003 (N/A), 722010 ((01)00884838059030(21)754, (01)00884838059030(21)42, (01)00884838059030(21)500, (01)00884838059030(21)68, (01)00884838059030(21)521, (01)00884838059030(21)33, (01)00884838059030(21)1025, (01)00884838059030(21)668, (01)00884838059030(21)585, (01)00884838059030(21)641, (01)00884838059030(21)968, (01)00884838059030(21)890, (01)00884838059030(21)780, (01)00884838059030(21)667, (01)00884838059030(21)1279, (01)00884838059030(21)344, (01)00884838059030(21)359, (01)00884838059030(21)423, (01)00884838059030(21)1040, (01)00884838059030(21)478, (01)00884838059030(21)215, (01)00884838059030(21)1298, (01)00884838059030(21)970, (01)00884838059030(21)1226, (01)00884838059030(21)365, (01)00884838059030(21)1328, (01)00884838059030(21)1292, (01)00884838059030(21)1275, (01)00884838059030(21)755, (01)00884838059030(21)671, (01)00884838059030(21)677, (01)00884838059030(21)61, (01)00884838059030(21)477, (01)00884838059030(21)1078, (01)00884838059030(21)327, (01)00884838059030(21)65, (01)00884838059030(21)1369, (01)00884838059030(21)792, (01)00884838059030(21)679, (01)00884838059030(21)479, (01)00884838059030(21)485, (01)00884838059030(21)592, (01)00884838059030(21)229, (01)00884838059030(21)119, (01)00884838059030(21)662, (01)00884838059030(21)1235, (01)00884838059030(21)1214, (01)00884838059030(21)764, (01)00884838059030(21)902, (01)00884838059030(21)1344, (01)00884838059030(21)675, (01)00884838059030(21)191, (01)00884838059030(21)937, (01)00884838059030(21)1432, (01)00884838059030(21)308, (01)00884838059030(21)833, (01)00884838059030(21)1310, (01)00884838059030(21)728, (01)00884838059030(21)791, (01)00884838059030(21)987, (01)00884838059030(21)986, (01)00884838059030(21)1005, (01)00884838059030(21)1425, (01)00884838059030(21)965, (01)00884838059030(21)1132, (01)00884838059030(21)468, (01)00884838059030(21)527, (01)00884838059030(21)1442, (01)00884838059030(21)646, (01)00884838059030(21)648…
The hazard
Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US Nationwide distribution.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)
Canada