United StatesAllura Xper FD interventional fluoroscopic x‑ray systems bearing model numbers 722026, 722027, 722028, 722029, 722035, 722038, 722039 or 722058 (software version R8.2 and the listed UDI numbers) are affected. They were recalled because a firmware issue can potentially lead to loss of geometry movements.
What's being recalled
Allura Xper FD. Model Numbers: 722026, 722027, 722028, 722029, 722035, 722038, 722039, 722058. Interventional fluoroscopic x-ray system.
Recalling firm: Philips Medical Systems Nederland B.V., Best, Netherlands.
How to identify it
Model Numbers: 722026, 722027, 722028, 722029, 722035, 722038, 722039, 722058. Software Version: R8.2. UDI Numbers: (01)00884838054202(21)1756, (01)00884838054202(21)1569, (01)00884838059115(21)100, (01)00884838059115(21)239, (01)00884838054202(21)520, (01)00884838054202(21)1956, (01)00884838054189(21)683, (01)00884838054196(21)351, (01)00884838054202(21)129, (01)00884838059115(21)305, (01)00884838054196(21)332, (01)00884838054202(21)1233, (01)00884838054202(21)2206, (01)00884838054202(21)1690, (01)00884838054202(21)928, (01)00884838054189(21)155, (01)00884838054202(21)317, (01)00884838054202(21)1774, (01)00884838054202(21)2502, (01)00884838054202(21)869, (01)00884838054202(21)668, (01)00884838054189(21)618, (01)00884838054189(21)1051, (01)00884838054189(21)1052, (01)00884838054202(21)406, (01)00884838054202(21)540, (01)00884838054202(21)548, (01)00884838054202(21)1017, (01)00884838054202(21)590, (01)00884838054189(21)654, (01)00884838054189(21)786, (01)00884838054196(21)216, (01)00884838054196(21)230, (01)00884838054202(21)596, (01)00884838054202(21)1957, (01)00884838054202(21)110, (01)00884838054202(21)2261, (01)00884838054189(21)1132, (01)00884838054226(21)115, (01)00884838059115(21)259, (01)00884838054202(21)173, (01)00884838054202(21)866, (01)00884838054202(21)1310, (01)00884838059115(21)203, (01)00884838054202(21)1043, (01)00884838054189(21)458, (01)00884838054202(21)466, (01)00884838054226(21)42, (01)00884838054202(21)1077, (01)00884838059115(21)373, (01)00884838054202(21)877, (01)00884838054202(21)896, (01)00884838054202(21)987, (01)00884838054202(21)995, (01)00884838054202(21)1343, (01)00884838054202(21)1439, (01)00884838059115(21)111, (01)00884838054202(21)895, (01)00884838054202(21)265, (01)00884838054202(21)305, (01)00884838054189(21)1100, (01)00884838054189(21)770, (01)00884838054196(21)1, (01)00884838054202(21)1154, (01)00884838054196(21)71, (01)00884838054202(21)1000, (01)00884838054202(21)1909, (01)00884838054202(21)121, (01)00884838054189(21)436…
The hazard
Firmware issue potentially leading to loss of geometry movements.
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, Algeria, Argentina, Australia, Austria, Bangladesh, Belarus, Belgium, Brazil, Bulgaria, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, French Polynesia, Germany, Greece, Guinea, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kosovo, Lao, Lebanon, Lithuania, Malaysia, Maldives, Malta, Martinique, Mexico, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Caledonia, Norway, Oman, Pakistan, Palestine, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Fed., Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Taiwan, Tanzania, Thailand, Trinidad & Tobago, Tunisia, T¿rkiye, Ukraine, United Kingdom, Uruguay, United Arab Emirates, 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)
Canada