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. 989605409282, 989605438511, 989605357141, 989605357143, 989605427801; UDI: (01)00884838061446(21)B22RP6, (01)00884838061446(21)F01N54, (01)00884838061446(21)B28KXP, (01)00884838061446(21)B2HRV1, (01)00884838061446(21)F0HR2C, (01)00884838061446(21)B2K24P, (01)00884838061446(21)B2L7JQ, (01)00884838061446(21)B3D77Q, (01)00884838061446(21)F02MHJ, (01)00884838061446(21)B21DYX, (01)00884838061781(21)B1Z20M, (01)00884838061781(21)B22QTZ, (01)00884838061781(21)B26888, (01)00884838061781(21)B28KXF, (01)00884838061446(21)B29X6N, (01)00884838061446(21)B37K59, (01)00884838061446(21)B2F0XT, (01)00884838061781(21)B305VR, (01)00884838061781(21)B3BPQL, (01)00884838061446(21)F0CFRQ, (01)00884838061446(21)B2L8ZT, (01)00884838061446(21)B1JBW3, (01)00884838061446(21)B1JD06, (01)00884838061446(21)B1JFHH, (01)00884838061446(21)F00PZJ, (01)00884838061446(21)B29Y6B, (01)00884838061446(21)B2RWK0, (01)00884838061446(21)B305W1, (01)00884838061446(21)B1JCTV, (01)00884838061446(21)F04123, (01)00884838061446(21)F0DDD7, (01)00884838061446(21)F09980, (01)00884838061446(21)F09Y27, (01)00884838061446(21)F02G1Q, (01)00884838061446(21)B28HZ1, (01)00884838061446(21)B28KXB, (01)00884838061446(21)B2K9WV, (01)00884838061446(21)B1JC08, (01)00884838061446(21)B1JCTW, (01)00884838061446(21)B1JCXY, (01)00884838061446(21)B2FC7Y, (01)00884838061781(21)B27YFD, (01)00884838061446(21)F00HW1, (01)00884838061446(21)B2B3JB, (01)00884838061446(21)B2D297, (01)00884838061446(21)B2DYJC, (01)00884838061446(21)F02RT6, (01)0
989605409282, 989605438511, 989605357141, 989605357143, 989605427801, 00884838061446, 00884838061781
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.