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. 989605431531, 989605456291, 989605391092, 989605412062, 989605409562; UDI: (01)00884838070806(21)B3DVRN, (01)00884838070806(21)B3NTCY, (01)00884838070806(21)F05K3C, (01)00884838070813(21)B3J1RW, (01)00884838070813(21)B3KZY9, (01)00884838070813(21)F04T5F, (01)00884838070813(21)F0952L, (01)00884838070813(21)F0DYQG, (01)00884838070813(21)F0KLBR, 010088483807080621F01T01, (01)00884838070813(21)F0LWXK, (01)00884838070813(21)F0GMZ9, (01)00884838070806(21)F0JYQZ, (01)00884838070813(21)F0GN24, 010088483807081321F0FT37, 010088483807081321F0GD1D, 010088483807081321F0GDDJ, (01)00884838070806(21)B39ZR0, (01)00884838070806(21)B3BYRP, (01)00884838070806(21)B3KRZF, (01)00884838070813(21)F0LV0Z, (01)00884838070806(21)B3KRZG, (01)00884838070806(21)F04836, (01)00884838070806(21)F04N2M, (01)00884838070813(21)B3JQW5, (01)00884838070813(21)B3VGVT, (01)00884838070806(21)F03QB1, (01)00884838070806(21)F03XVR, (01)00884838070813(21)F089C4, (01)00884838070806(21)F0GTGK, (01)00884838070806(21)F0LDQ9, (01)00884838070806(21)F0BPTR, (01)00884838070806(21)F0JYQT, (01)00884838070806(21)F0JYR1, (01)00884838070806(21)B35Y87, (01)00884838070806(21)F0CXZH, (01)00884838070806(21)F0KW6H, (01)00884838070813(21)F05WMG, (01)00884838070813(21)F0F0KX, (01)00884838070813(21)F0GV7P, (01)00884838070806(21)F047WP, (01)00884838070806(21)F04D44, (01)00884838070806(21)F08XGX, (01)00884838070806(21)F0L6W6, (01)00884838070806(21)F031MC, (01)00884838070813(21)F0KPXQ, (01)00884838070813(21)F0KQZY, (01)00884838070806(21
989605431531, 989605456291, 989605391092, 989605412062, 989605409562, 00884838070806, 00884838070813
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.