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. 989605450353, 989605450352, 989605477131, 989605450351, 989605451181, 989605427371; UDI: 010088483808517621F0FYRG, (01)00884838085176(21)B3H57K, (01)00884838068766(21)B1W1CR, (01)00884838086555(21)B2C7Z5, (01)00884838085176(21)F07VCW, (01)00884838085176(21)F0J0P8, (01)00884838061828(21)B1MBZM, (01)00884838068766(21)B1W1NG, (01)00884838085176(21)B1MC3H, (01)00884838085176(21)B1QHPM, (01)00884838085176(21)B1W13D, (01)00884838085176(21)B1W153, (01)00884838085176(21)B27BC5, (01)00884838085176(21)B3PH0F, (01)00884838085176(21)B3R48C, (01)00884838085176(21)F02N98, (01)00884838085176(21)F07PWD, (01)00884838085176(21)F07TZ0, (01)00884838085176(21)F07Y64, (01)00884838085176(21)F081Y3, (01)00884838085176(21)F082NG, (01)00884838085176(21)F082NP, (01)00884838085176(21)F0855V, (01)00884838085176(21)F088RF, (01)00884838085176(21)F089MZ, (01)00884838085176(21)F089N6, (01)00884838085176(21)F08GBG, (01)00884838085176(21)F08GBX, (01)00884838085176(21)F08HWH, (01)00884838085176(21)F08KFK, (01)00884838085176(21)F08NKZ, (01)00884838085176(21)F08NL0, (01)00884838085176(21)F08NLH, (01)00884838085176(21)F08PR7, (01)00884838085176(21)F08PR8, (01)00884838085176(21)F08PR9, (01)00884838085176(21)F08PRB, (01)00884838085176(21)F08PRF, (01)00884838085176(21)F08WGJ, (01)00884838085176(21)F08ZVL, (01)00884838085176(21)F091X3, (01)00884838085176(21)F091X6, (01)00884838085176(21)F091X8, (01)00884838085176(21)F091X9, (01)00884838085176(21)F092MC, (01)00884838085176(21)F092MG, (01)00884838085176(21)F0B
989605450353, 989605450352, 989605477131, 989605450351, 989605451181, 989605427371, 00884838085176, 00884838068766, 00884838086555, 00884838061828, 00884838072312
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.