United StatesPhilips Azurion imaging systems not configured with the optional auxiliary pan handle — including Azurion 3 M12, 3 M15, 5 M12, 5 M20, 7 B12, 7 B20, 7 M12, and 7 M20 model families — are affected. They were recalled because mechanical wear of the Float Tabletop control on the control module may impact longitudinal and transverse table movements.
What's being recalled
Philips Azurion systems not configured with an optional auxiliary pan handle. Includes the below product descriptions and corresponding model numbers. 1. Azurion 3 M12; Model Numbers: 722063, 722229. 2. Azurion 3 M15; Model Numbers: 722222, 722064, 722280, 722230. 3. Azurion 5 M12; Model Numbers: 722227, 722231. 4. Azurion 5 M20; Model Numbers: 722228, 722232, 722281. 5. Azurion 7 B12; Model Numbers: 722067, 722225, 722235. 6. Azurion 7 B20; Model Numbers: 722068, 722226, 722236. 7. Azurion 7 M12; Model Numbers: 722078, 722223, 722233. 8. Azurion 7 M20; Model Numbers: 722079, 722224, 722234, 722282.
Recalling firm: Philips Medical Systems Nederland B.V., Best, Netherlands.
How to identify it
1. Model Number [UDI]: 722063 [(01)00884838085275(21)77, (01)00884838085275(21)47, (01)00884838085275(21)146, (01)00884838085275(21)102, (01)00884838085275(21)43, (01)00884838085275(21)2, (01)00884838085275(21)99, (01)00884838085275(21)28, (01)00884838085275(21)144, (01)00884838085275(21)62, (01)00884838085275(21)119, (01)00884838085275(21)61, (01)00884838085275(21)29, (01)00884838085275(21)40, (01)00884838085275(21)70, (01)00884838085275(21)120, (01)00884838085275(21)121, (01)00884838085275(21)110, (01)00884838085275(21)53, (01)00884838085275(21)103, (01)00884838085275(21)97, (01)00884838085275(21)101, (01)00884838085275(21)143, (01)00884838085275(21)116, (01)00884838085275(21)93, (01)00884838085275(21)141, (01)00884838085275(21)115, (01)00884838085275(21)137, (01)00884838085275(21)150, (01)00884838085275(21)128, (01)00884838085275(21)4, (01)00884838085275(21)50, (01)00884838085275(21)129, (01)00884838085275(21)78, (01)00884838085275(21)76, (01)00884838085275(21)69, (01)00884838085275(21)59, (01)00884838085275(21)92, (01)00884838085275(21)139, (01)00884838085275(21)130, (01)00884838085275(21)154, (01)00884838085275(21)75, (01)00884838085275(21)24, (01)00884838085275(21)94, (01)00884838085275(21)100, (01)00884838085275(21)26, (01)00884838085275(21)106, (01)00884838085275(21)37, (01)00884838085275(21)36, (01)00884838085275(21)27, (01)00884838085275(21)15, (01)00884838085275(21)135, (01)00884838085275(21)123, (01)00884838085275(21)87, (01)00884838085275(21)85, (01)00884838085275(21)89, (01)00884838085275(21)88, (01)00884838085275(21)86, (01)00884838085275(21)90, (01)00884838085275(21)91, (01)00884838085275(21)79, (01)00884838085275(21)133, (01)00884838085275(21)81, (01)00884838085275(21)52, (01)00884838085275(21)48, (01)00884838085275(21)148, (01)00884838085275(21)55]; 722229 [(01)00884838116726(21)7, (01)00884838116726(21)3, (01)00884838116726(21)10, (01)00884838116726(21)11, (01)00884838116726(21)21, (01)00884838116726(21)13]. 2. Model Number [UDI]: 722064…
The hazard
Potential safety issue with Philips Azurion systems, where longitudinal and transverse table movements may be impacted due to mechanical wear of the Float Tabletop control on the control module.
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
Nationwide distribution. International distribution to Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Canada, Chile, C¿te D'Ivoire, El Salvador, Estonia, Greece, Honduras, Hong Kong, Iceland, Indonesia, Iraq, Japan, Kyrgyzstan, Malaysia, Malta, Moldova, Nepal, New Zealand, Philippines, Qatar, Singapore, South Africa, Sri Lanka, Syrian Arab Republic, Tanzania, Turkmenistan, Vietnam, Yemen
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