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. 989605400812, 989605439971, 989605347573, 989605347571, 989605388121; UDI: (01)00884838061576(21)B2WXR8, (01)00884838061576(21)B2X94P, (01)00884838061576(21)B2YH00, (01)00884838061576(21)B3RTXC, (01)00884838061576(21)F01P42, (01)00884838061576(21)F04HQ8, (01)00884838061576(21)F06JLT, (01)00884838061576(21)F06M72, (01)00884838061576(21)F0FBV2, (01)00884838061576(21)F0FF0X, (01)00884838061576(21)F0GNFR, (01)00884838061576(21)F00XMF, (01)00884838061576(21)F05RCP, (01)00884838061576(21)F0GNFP, (01)00884838061576(21)B2FXP7, (01)00884838061576(21)F0DN5J, (01)00884838061576(21)B287Y8, (01)00884838061576(21)B2846C, (01)00884838061576(21)B28KC3, (01)00884838061576(21)B295K0, (01)00884838061576(21)B29731, (01)00884838061576(21)F091ZZ, (01)00884838061576(21)F0BXFT, (01)00884838061576(21)F0BXFV, (01)00884838061576(21)F0K9R8, 010088483806157621F0G8ZT, (01)00884838061576(21)B3F4KZ, (01)00884838061576(21)F04LFV, (01)00884838061576(21)B1W955, (01)00884838061576(21)F00W1B, (01)00884838061576(21)F0JBTM, (01)00884838061576(21)F099KN, (01)00884838061576(21)F099KQ, (01)00884838061576(21)F09CG3, (01)00884838061576(21)F0BC4Z, (01)00884838061576(21)B21DV7, (01)00884838061576(21)B21DVC, (01)00884838061576(21)B22QZ4, (01)00884838061576(21)B238LY, (01)00884838061576(21)B288Q4, (01)00884838061576(21)B2T82X, (01)00884838061576(21)B2T9M3, (01)00884838061576(21)B2VT3W, (01)00884838061576(21)F02NR0, (01)00884838061576(21)F04GLB, (01)00884838061576(21)F04LFZ, (01)00884838061576(21)F0506K, (01)00884
989605400812, 989605439971, 989605347573, 989605347571, 989605388121, 00884838061576, 00884838061729
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.