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. 989605412072, 989605492481, 989605438571, 989605430253, 989605348243, 989605412071, 989605366211, 989605412042, 989605387241, 989605400521, 21475A, 989605456291; UDI: (01)00884838061620(21)B1WH6H, (01)00884838061620(21)B1WK9N, (01)00884838061620(21)B2278N, (01)00884838061620(21)B2ZC90, (01)00884838061620(21)B3GLHC, (01)00884838061620(21)B3KQWJ, (01)00884838061620(21)B3RB89, (01)00884838061620(21)F0112F, (01)00884838090804(21)B3F4N0, (01)00884838090804(21)B3NJZK, (01)00884838090804(21)F04ZGP, (01)00884838090804(21)F06W70, (01)00884838090804(21)F0B5FT, (01)00884838090804(21)F0D97N, (01)00884838090804(21)F0KNM8, 010088483809080421F021KZ, 010088483809080421F023DB, (01)00884838090804(21)F0LJNK, N/A, (01)00884838061620(21)B3BTG6, (01)00884838090804(21)F0K3YK, (01)00884838061620(21)F0KJT5, (01)00884838061620(21)B1QMN8, (01)00884838061620(21)B24X8V, (01)00884838061620(21)B24XKZ, 010088483809080421F0G2BJ, (01)00884838061620(21)B20XVR, (01)00884838061620(21)F06NV0, (01)00884838061620(21)F0CB3Z, (01)00884838090804(21)F0CX7C, (01)00884838061620(21)F0LB13, (01)00884838090804(21)B351B4, (01)00884838090804(21)B3JV93, (01)00884838061620(21)F04T3X, (01)00884838061620(21)F05CFK, (01)00884838090804(21)F012JG, (01)00884838061620(21)B2NX9G, (01)00884838061620(21)B2NXH7, (01)00884838061620(21)B2Q9B5, (01)00884838061620(21)B2YRFC, (01)00884838090804(21)B3JGWH, (01)00884838090804(21)B3JV8R, (01)00884838090804(21)F04HD2, (01)00884838090804(21)F04M2G, 010088483806162021F0293W, (01)0088483806
989605412072, 989605492481, 989605438571, 989605430253, 989605348243, 989605412071, 989605366211, 989605412042, 989605387241, 989605400521, 989605456291, 00884838061620, 00884838090804, 00884838068025, 00884838061736, 00884838061613
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.