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. 989605358813, 989605371711, 989605371713, 989605386651, 989605387521, 989605389241, 989605389242, 989605398211, 989605399561, 989605418972, 989605430242, 989605451181, 989605454101, 989803002675; UDI: Unique Device Identifier (UDI), (01)00884838067424(21)B200XV, (01)00884838067424(21)B2W963, (01)00884838067424(21)B2XQ5R, (01)00884838067424(21)B31MDB, (01)00884838067424(21)B2BBY9, (01)00884838067424(21)B2C5FJ, (01)00884838067424(21)B329WV, (01)00884838067424(21)B3CWGT, (01)00884838067424, (01)00884838067424(21)F05G0L, (01)00884838061385(21)B1PKRD, (01)00884838067424(21)B224J4, (01)00884838067424(21)B224J7, (01)00884838067424(21)B224JX, (01)00884838067424(21)B224JZ, (01)00884838067424(21)B224MQ, (01)00884838067424(21)B2M756, (01)00884838067424(21)B2M75Q, (01)00884838067424(21)B2M776, (01)00884838067424(21)B34T1T, (01)00884838067424(21)B35Y9P, (01)00884838067424(21)B36LTF, (01)00884838068018(21)B24HQ5, (01)00884838067424(21)F07YGL, (01)00884838067424(21)B2HNC4, (01)00884838067943(21)B35H7Y, (01)00884838061385(21)B18L9Q, (01)00884838067424(21)B2L1Y0, (01)00884838067424(21)B2JX1Q, (01)00884838067424(21)F04LFN, (01)00884838068018(21)B27Q4P, (01)00884838068018(21)B27RCK, (01)00884838067943(21)B2PW77, (01)00884838067424(21)F011BB, (01)00884838068018(21)B27G1F, (01)00884838068018(21)B27ND4, (01)00884838068018(21)B27T3X, (01)00884838061385(21)B1TPP1, (01)00884838067424(21)B34T0G, (01)00884838061385(21)B1NMBP, (01)00884838061804(21)B1NLZK, (01)00884838061804(21)B1F3K0, (01)008
989605358813, 989605371711, 989605371713, 989605386651, 989605387521, 989605389241, 989605389242, 989605398211, 989605399561, 989605418972, 989605430242, 989605451181, 989605454101, 989803002675, 00884838067424, 00884838061385, 00884838068018, 00884838067943, 00884838061804, 00884838067738, 00884838072312, 00884838067875
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.