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. 989605472101, 989605400802, 989605361882; UDI: (01)00884838086609(21)B2Y9BP, (01)00884838086609(21)B3GMC1, 010088483808660921F0G6T9, (01)00884838086609(21)B3M9F7, (01)00884838086609(21)F088D0, (01)00884838086609(21)F08K67, (01)00884838086609(21)F08XLT, (01)00884838086609(21)F092KQ, (01)00884838086609(21)F011V7, (01)00884838086609(21)F011VC, (01)00884838086609(21)F089HB, 010088483808660921F01Q7H, (01)00884838086609(21)F02N9G, (01)00884838086609(21)B23VNV, (01)00884838086609(21)B3R9CQ, (01)00884838086609(21)B3RFQL, (01)00884838086609(21)F01QK3, (01)00884838086609(21)F04FDY, (01)00884838086609(21)F06V0P, (01)00884838086609(21)F06ZF3, (01)00884838086609(21)F0FF6Y, (01)00884838086609(21)F0FHLF, 010088483808660921F0GH6F, N/A, (01)00884838086609(21)B2R8CV, (01)00884838086609(21)F04HG7, (01)00884838086609(21)F0CM8H, (01)00884838086609(21)F08VD8, (01)00884838086609(21)F0HCFG, (01)00884838086609(21)B2Z070, (01)00884838086609(21)F06B02, (01)00884838086609(21)B32B8K, (01)00884838086609(21)F037HK, (01)00884838086609(21)F09YHV, (01)00884838086609(21)F04291, (01)00884838086609(21)F05RCY, 010088483808660921F0GDDT, (01)00884838086609(21)B23VXQ, (01)00884838086609(21)F0D7ZG, (01)00884838086609(21)B23VP8, (01)00884838086609(21)F058QY, (01)00884838086609(21)F09151, (01)00884838086609(21)F0K3M2, (01)00884838086609(21)F064TX, (01)00884838086609(21)F066ZX, (01)00884838086609(21)B3J1W3, (01)00884838086609(21)B2R8KR, (01)00884838086609(21)F08LPL, (01)00884838086609(21)F08N2Q, (01)0088483808
989605472101, 989605400802, 989605361882, 00884838086609
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.