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. 989605414692, 989605463421, 989605442131, 989605387731, 989605412042, 989605430222, 989605381211, 989605430652, 989605361982, 989605463421; UDI: (01)00884838067844(21)B2TH04, (01)00884838067844(21)B2TH20, (01)00884838067844(21)B2TH5R, (01)00884838067844(21)B2TH94, (01)00884838067844(21)B2TH95, (01)00884838067844(21)B2TRZG, (01)04719873000067(21)F0771Y, (01)04719873000067(21)F0K891, 010471987300006721B24RHN, (01)00884838067844(21)B2ZLWP, (01)00884838067844(21)B1N04C, (01)00884838067844(21)B1N0D2, (01)00884838067844(21)B2PXTV, (01)00884838067844(21)B2PY5Z, (01)00884838067844(21)B2TRRF, (01)00884838067844(21)B1RDM4, (01)04719873000067(21)B3TLRJ, (01)04719873000067(21)B3VZCQ, (01)00884838067844(21)B35KQ5, (01)00884838067844(21)B2ZLK8, (01)00884838067844(21)B2ZTKD, (01)00884838067844(21)B1JVZF, (01)00884838067844(21)F0G5KZ, (01)00884838067844(21)B20GTL, (01)00884838067844(21)B20QB6, 010088483806784421F0B41N, 010088483806784421F0B41W, (01)00884838067844(21)B2PTGM, (01)00884838067844(21)B2TGKT, (01)00884838067844(21)B2TGL2, (01)00884838067844(21)B2TH12, (01)00884838067844(21)B1RF7C, (01)00884838067844(21)B2ZTKF, (01)00884838067844(21)B3W869, (01)00884838067844(21)B3TJP3, (01)00884838067844(21)B3TJWM, 010088483806784421B3Y0V9, (01)00884838067844(21)B2DC5Z, (01)00884838067844(21)B2PN5J, (01)00884838067844(21)F0HWVH, (01)00884838067844(21)F0HYM4, (01)00884838067844(21)F0J4F6, (01)00884838067844(21)F0LH1L, (01)00884838067844(21)B1WVHX, (01)00884838067844(21)B27QW7, (01)0088483
989605414692, 989605463421, 989605442131, 989605387731, 989605412042, 989605430222, 989605381211, 989605430652, 989605361982, 00884838067844, 04719873000067, 00884838061613, 00884838068049, 00884838061484
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.