Ceiling mounted L-arm contains a rotation cover that may potentially be susceptible to falling if a collision between the L-arm and other hospital equipment (i.e., an operating light) were to occur result in injury or potential sterility issues due to the cover becoming loose
Reason for recall: Ceiling mounted L-arm contains a rotation cover that may potentially be susceptible to falling if a collision between the L-arm and other hospital equipment (i.e., an operating light) were to occur result in injury or potential sterility issues due to the cover becoming loose Distribution: Worldwide - US Nationwide and the countries of Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, CANADA, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Curacao, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Fiji, Finland, France, French Polynesia, Quantity: 9991 units Lot/code info: Model/Name/UDI-DI: 722001 Allura Xper FD10C; 722003 Allura Xper FD10; 722006 Allura Xper FD20 (01)00884838059115(21); 722010 Allura Xper FD10 (01)00884838059030(21); 722012 Allura Xper FD20 (01)00884838059054(21); 722015 Allura Xper FD20 OR Table; 722016 Integris H5000 C / Allura 9C ; 722018 Integris Allura 9; - 722022 Allura Xper FD10 OR Table; 722023 Allura Xper FD20 OR Table (01)00884838059085(21;) 722026 Allura Xper FD10 (01)00884838054189(21); 722028 Allura Xper FD20 (01)00884838054202(21); 722035 Allura Xper FD20 OR Table (01)00884838054240(21); 722043 Integris Allura 15 & 12 (monoplane).
00884838059115, 00884838059030, 00884838059054, 00884838059085, 00884838054189, 00884838054202, 00884838054240
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.