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. 989605412102, 989605438591; UDI: (01)00884838061361(21)B1N4HT, (01)00884838061361(21)B1N4J6, (01)00884838061361(21)B2L6QZ, (01)00884838061361(21)B2L6R0, (01)00884838061361(21)B2L6T9, (01)00884838061361(21)F01C9Y, (01)00884838061361(21)F074NX, (01)00884838061361(21)B2Q7FK, (01)00884838061361(21)F08MVZ, (01)00884838061361(21)B1NDJD, (01)00884838061361(21)B1N4JF, (01)00884838061361(21)B2L6TV, (01)00884838061361(21)F05Z77, (01)00884838061361(21)B2Q71X, (01)00884838061361(21)F0998F, (01)00884838061361(21)F0998J, (01)00884838061361(21)F09WC4, (01)00884838061361(21)F02H8Q, (01)00884838061361(21)F07JPJ, (01)00884838061361(21)F00LFM, (01)00884838061361(21)F00LFN, (01)00884838061361(21)B2Q7FT, (01)00884838061361(21)B2L6RJ, (01)00884838061361(21)B2L6RF, (01)00884838061361(21)B1N4KJ, (01)00884838061361(21)F067C1, (01)00884838061361(21)F068GD, (01)00884838061361(21)B1N4JR, (01)00884838061361(21)B2Q7FZ, (01)00884838061361(21)F01J0W, (01)00884838061361(21)B2Q71V, (01)00884838061361(21)B2Q71W, (01)00884838061361(21)B1N4HG, (01)00884838061361(21)F01J0R, (01)00884838061361(21)F0BBGN, (01)00884838061361(21)F0BFWZ, (01)00884838061361(21)F00436, (01)00884838061361(21)F00K75, (01)00884838061361(21)F00K76, (01)00884838061361(21)B2L6QD, (01)00884838061361(21)B2L6QW, (01)00884838061361(21)B2L6R1, (01)00884838061361(21)F04KMV, (01)00884838061361(21)F04KMW, (01)00884838061361(21)F04LKF, (01)00884838061361(21)B2L6TW, (01)00884838061361(21)B1N4JK, (01)00884838061361(21)B2L6T1, (01)0088483806136
989605412102, 989605438591, 00884838061361
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.