Philips Azurion systems (models Azurion 3 M12 722063/722221; 3 M15 722064/722222; 5 M12 722227; 5 M20 722228; 7 B12 722067/722225; 7 B20 722068/722226; 7 M12 722078/722223; 7 M20 722079/722224) and Philips Allura Xper systems (Allura Xper FD10, FD20 and listed OR table and biplane variants) are affected. Hard disk drives used in the PCs of these systems may show decreased performance as they age, particularly beyond six years, which can result in loss of imaging functionality; in Allura systems this may also cause loss of motorized movement or loss of data, and a restart may temporarily restore functionality.
What's being recalled
Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063, 722221), Azurion 3 M15 (722064, 722222), Azurion 5 M12 (722227), Azurion 5 M20 (722228), Azurion 7 B12 (722067, 722225), Azurion 7 B20 (722068, 722226), Azurion 7 M12 (722078, 722223), Azurion 7 M20 (722079, 722224).
Allura system; System Code Description (Model Numbers): Allura Xper FD10 (722003, 722010, 722026), Allura Xper FD10 OR Table (722022, 722033), Allura Xper FD10/10 (722005, 722011, 722027), Allura Xper FD20 (722006, 722012, 722028), Allura Xper FD20 Biplane (722008, 722013), Allura Xper FD20 OR Table (722015, 722023, 722035), Allura Xper FD20 Biplane OR Table (722025), Allura Xper FD20/10 (722029), Allura Xper FD20/15 (722058), Allura Xper FD20/15 OR Table (722059), Allura Xper FD20/20 (722038), Allura Xper FD20/20 OR Table (722039);
Recalling firm: Philips Medical Systems Nederland B.V., Best, Netherlands.
How to identify it
1. Azurion 3 M12; Model: 722063; UDI: (01)00884838085275(21)122, (01)00884838085275(21)64, (01)00884838085275(21)56, (01)00884838085275(21)131, (01)00884838085275(21)84, (01)00884838085275(21)132, (01)00884838085275(21)98, (01)00884838085275(21)108, (01)00884838085275(21)77, (01)00884838085275(21)82, (01)00884838085275(21)47, (01)00884838085275(21)80, (01)00884838085275(21)146, (01)00884838085275(21)102, (01)00884838085275(21)117, (01)00884838085275(21)2, (01)00884838085275(21)149, (01)00884838085275(21)99, (01)00884838085275(21)44, (01)00884838085275(21)3, (01)00884838085275(21)28, (01)00884838085275(21)144, (01)00884838085275(21)62, (01)00884838085275(21)119, (01)00884838085275(21)61, (01)00884838085275(21)22, (01)00884838085275(21)29, (01)00884838085275(21)40, (01)00884838085275(21)70, (01)00884838085275(21)30, (01)00884838085275(21)25, (01)00884838085275(21)19, (01)00884838085275(21)120, (01)00884838085275(21)121, (01)00884838085275(21)110, (01)00884838085275(21)16, (01)00884838085275(21)14, (01)00884838085275(21)17, (01)00884838085275(21)53, (01)00884838085275(21)103, (01)00884838085275(21)101, (01)00884838085275(21)143, (01)00884838085275(21)41, (01)00884838085275(21)104, (01)00884838085275(21)116, (01)00884838085275(21)151, (01)00884838085275(21)93, (01)00884838085275(21)141, (01)00884838085275(21)115, (01)00884838085275(21)73, (01)00884838085275(21)150, (01)00884838085275(21)128, (01)00884838085275(21)105, (01)00884838085275(21)4, (01)00884838085275(21)50, (01)00884838085275(21)129, (01)00884838085275(21)72, (01)00884838085275(21)38, (01)00884838085275(21)21, (01)00884838085275(21)78, (01)00884838085275(21)23, (01)00884838085275(21)76, (01)00884838085275(21)63, (01)00884838085275(21)69, (01)00884838085275(21)59, (01)00884838085275(21)51, (01)00884838085275(21)92, (01)00884838085275(21)139, (01)00884838085275(21)130, (01)00884838085275(21)75, (01)00884838085275(21)24, (01)00884838085275(21)94, (01)00884838085275(21)100, (01)00884838085275(21)54…
The hazard
It was identified that HDDs used in the PCs of Azurion and Allura systems may show a decrease in performance as they age, particularly beyond six years of service. Issues with an HDD may, depending on the specific system PC in which the affected HDD is installed, result in loss of imaging functionality. Additionally, in Allura systems, this may lead to loss of motorized movement, or loss of data. In some cases, a system restart may temporarily restore functionality.
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
Worldwide distribution - US Nationwide and the countries of Canada, Afghanistan, Albania, Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Brunei Darussal, Bulgaria, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Fiji, Finland, France, French Polynesia, Georgia, Germany, Greece, Guinea, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, South, Kosovo, Kuwait, Kyrgyzstan, Lao, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritius, Mexico, Moldova, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Fed., Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, 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)