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. 8500-1662-01, 989605366373, 989605388061, 989605366371; UDI: (01)00884838064614(21)B20XYG, (01)00884838064614(21)B2HK04, (01)00884838064614(21)B36C77, (01)00884838064614(21)B22N5X, (01)00884838064614(21)B1YQ5T, (01)00884838064614(21)B30M34, (01)00884838064614(21)B3GX1Q, (01)00884838064614(21)B3H0X1, (01)00884838064614(21)B3P6N2, (01)00884838064614(21)B22N0X, (01)00884838064614(21)B2YF79, (01)00884838064614(21)B1XRFM, (01)00884838064614(21)B2YD0X, (01)00884838064614(21)B3BZNW, (01)00884838064614(21)B2YNKW, (01)00884838064614(21)B1QBQ1, (01)00884838064614(21)B1W401, (01)00884838064614(21)B28MR6, (01)00884838064614(21)B30M32, (01)00884838064614(21)B31CR5, (01)00884838064614(21)B3MJMX, (01)00884838064614(21)B3MK52, (01)00884838064614(21)F093DP, (01)00884838064614(21)B2JDWW, (01)00884838064614(21)B2KN10, (01)00884838064614(21)B1ZR3M, (01)00884838064614(21)B1TVHQ, (01)00884838064614(21)B2NQ1G, (01)00884838064614(21)B1VL0Y, (01)00884838064614(21)B1Q3BM, (01)00884838064614(21)B31VQ3, (01)00884838064614(21)B2LM71, (01)00884838064614(21)F048JT, (01)00884838064614(21)B2ZC0V, (01)00884838064614(21)B2HTPC, (01)00884838064614(21)B326LT, (01)00884838064614(21)B3J3L3, (01)00884838064614(21)F02LCK, (01)00884838064614(21)B285BJ, (01)00884838064614(21)B2G3H4, (01)00884838064614(21)B3GX28, (01)00884838064614(21)B3H0X5, (01)00884838064614(21)B1VL2B, (01)00884838064614(21)B1Q3BL, (01)00884838064614(21)B289YG, (01)00884838064614(21)B1WGX0, (01)00884838064614(21)B1RT7M, (01)00884838064614(
989605366373, 989605388061, 989605366371, 00884838064614
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.