Ultrasound transducer devices were refurbished beyond their useful life.
Reason for recall: Ultrasound transducer devices were refurbished beyond their useful life. Distribution: Domestic: Nationwide Distribution; Foreign: Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, New Caledonia, New Zealand, Nicaragua, Oman, Philippines, P Quantity: 5,230 units Lot/code info: Model No. 989605440772, 989605440771, 989605439232, 989605406772, 989605439231, 989606708921, 989803002661; UDI: (01)00884838061439(21)B2103Y, (01)00884838061439(21)B1J2M7, (01)00884838061439(21)B2HX4N, (01)00884838061439(21)B187KZ, (01)00884838061439(21)B2HXHR, (01)00884838061439(21)B2104Q, (01)00884838061439(21)B178YZ, (01)00884838061439(21)B22VWR, (01)00884838061439(21)B37JGY, (01)00884838061439(21)B131BH, (01)00884838061439(21)B3DVFC, (01)00884838061439(21)B1BX6R, (01)00884838061439(21)B3JQF5, (01)00884838061439(21)B1GVLN, (01)00884838061439(21)B1WBJZ, (01)00884838061439(21)B3QBXJ, (01)00884838061439(21)B1ZKPV, (01)00884838061439(21)F01W1D, (01)00884838061439(21)B34PDQ, (01)00884838061439(21)B2HX16, (01)00884838061439(21)B3JQFH, (01)00884838061439(21)B3JQQ4, (01)00884838061439(21)B3DV7C, (01)00884838061439(21)B2HWZV, (01)00884838061439(21)B3DV6Y, (01)00884838061439(21)B37JJC, (01)00884838061439(21)B210C8, (01)00884838061439(21)B2HXBW, (01)00884838061439(21)B1FKLQ, (01)00884838061439(21)F001JV, (01)00884838061439(21)B2HX6C, (01)00884838061439(21)B18C91, (01)00884838061439(21)B3DV8Q, (01)00884838061439(21)B3JQFP, (01)00884838061439(21)B3DVCK, (01)00884838061439(21)B3DVCH, (01)00884838061439(21)B209GT, (01)00884838061439(21)B2106D, (01)00884838061439(21)B2HX29, (01)00884838061439(21)B3DVDC, (01)00884838061439(21)F03TQ7, (01)00884838061439(21)B1HHV9, (01)00884838061439(21)B0PK3Y, (01)00884838061439(21)B3JQQ0, (01)00884838061439(21)B3QBWT, (01)00884838061439(21)F001JQ, (01)008
989605440772, 989605440771, 989605439232, 989605406772, 989605439231, 989606708921, 989803002661, 00884838061439, 00884838067530
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.