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. 989605412082, 989605440682, 989605388091, 21314A, 989605438581, 989605361871, 989605412081, 989605961871, 989605391922, 989605387852, 989605440752, 989605412052, 989605361892, 989605384711, 989605400802; UDI: (01)00884838061637(21)B268VV, (01)00884838061637(21)B2BK4Q, (01)00884838061637(21)B2XV6D, (01)00884838061637(21)B2XVMK, (01)00884838061637(21)B3GLNL, (01)00884838061637(21)B3H17V, (01)00884838061637(21)B3H60B, (01)00884838061637(21)B3RBBZ, (01)00884838061637(21)F00X3V, (01)00884838061637(21)F055Z3, (01)00884838061637(21)F07YX6, (01)00884838061637(21)F0DZGY, (01)00884838061637(21)F0H3M1, (01)00884838061637(21)B3NT5N, (01)00884838061637(21)B1WFML, (01)00884838067561(21)B2BJQ4, (01)00884838067561(21)B2BK64, (01)00884838061637(21)B1Q2GH, (01)00884838061637(21)B1QVY3, 010088483806163721F0G049, (01)00884838061637(21)B3DGJ9, (01)00884838061637(21)F02WHD, (01)00884838061637(21)F0CM58, (01)00884838067561(21)B3D85G, (01)00884838067561(21)F0B3B2, (01)00884838061637(21)B1KYB4, (01)00884838061637(21)B1XMHD, (01)00884838061637(21)B1YT6J, (01)00884838061637(21)B35159, (01)00884838061637(21)F02KM5, (01)00884838061637(21)F0421R, (01)00884838061637(21)F062N7, (01)00884838061637(21)F0D3RL, (01)00884838067561(21)B1837D, (01)00884838067561(21)B19576, (01)00884838061637(21)B2WWLH, (01)00884838061637(21)B3JYHQ, 010088483806163721F02BZK, (01)00884838067561(21)F0918Z, (01)00884838061637(21)B28722, (01)00884838061637(21)F0CWJD, (01)00884838061637(21)F0D9N4, (01)00884838061637(21)B1WFGX,
989605412082, 989605440682, 989605388091, 989605438581, 989605361871, 989605412081, 989605961871, 989605391922, 989605387852, 989605440752, 989605412052, 989605361892, 989605384711, 989605400802, 00884838061637, 00884838067561, 00884838061
Official record: FDA (Device enforcement) ↗
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