To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Reason for recall: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. Distribution: US Nationwide distribution. Quantity: 171,322 units Lot/code info: Model No. 989605440702, 21378A; UDI: (01)00884838067585(21)B1CW9T, (01)00884838067585(21)B201MC, (01)00884838067585(21)B1CW9Q, (01)00884838067585(21)B1MK5D, (01)00884838067585(21)B1MK5X, (01)00884838067585(21)B198WH, (01)00884838067585(21)B1MKD9, (01)00884838067585(21)B198V3, (01)00884838067585(21)B201JF, (01)00884838067585(21)B201Q0, (01)00884838067585(21)B1991G, (01)00884838067585(21)B17X87, (01)00884838067585(21)B1MKC3, (01)00884838067585(21)B201QF, (01)00884838067585(21)B2FW9F, (01)00884838067585(21)B198VV, (01)00884838067585(21)B07FFB, (01)00884838067585(21)B2FW8Z, (01)00884838067585(21)B201N8, (01)00884838067585(21)B34R1B, (01)00884838067585(21)B05DX2, (01)00884838067585(21)B0LYR8, (01)00884838067585(21)B201K2, (01)00884838067585(21)B198Z2, (01)00884838067585(21)B1991B; Serial No. B1CW9T, 02Y7HM, 02VTGK, B201MC, B1CW9Q, 037CHG, 03G8B1, 03G0BB, B1MK5D, B1MK5X, 02WH6F, 033ZLX, 033W7Z, 03CWJM, 02QK2L, B198WH, 038MJ6, 037F68, B1MKD9, 038GL7, 0344C9, B04LK2, B1991F, B198V3, B1FTDM, 0341PJ, B201JF, 037HLM, 035R8K, B201Q0, B1FTFZ, 02QCRQ, B1991G, 02JL01, B1MK2K, B17X87, 02JJ0T, 031LC8, B1MKC3, B201QF, B1990H, B19918, 03FZXM, 039JWQ, 035PYK, 03436F, B2FW9F, 039PCB, B1MK2F, 031HN7, 02P8GV, B198VV, 02H0WW, 039HQ2, B07FFB, B2FW8Z, 02WJBB, B201N8, 02VP8P, B34R1B, 02YK1Q, B19900, 039Q2L, B05DX2, 02YCFD, 02WCTB, 039PC3, 035V3H, B0LYR8, B201K2, 02PDT7, 032MLN, 035P8R, 038LT2, B0M32G, 03G4GG, B0X7N7, 038HV5, 032MMK, 02QGKV, 028PNR, B198Z2, 032FKW, B198ZV, 03GZ12, 03191G, B1991B, B198ZK
989605440702, 00884838067585
Official record: FDA (Device enforcement) ↗
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