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. 989605353301, 989605353303, 989605387361; UDI: N/A; Serial No. B0ZTD1, 03F40C, 03923H, 0314BQ, 03712H, 033HGC, 03CJ9M, 035JY0, 03CFTH, 0399XP, 030FNL, 037R81, 02ZH61, 0358PF, 033JGV, 03FN82, 03230B, 03145Y, 02XYB3, 02XWH4, 02Z1D9, 03591C, 0359Q1, 03598Y, 035JVM, 02WVF0, 02WYT1, 03CFPG, 02XWN1, 02ZJR6, 02NV7G, 0305WC, 036XY3, 02XY9D, 03FNPD, 02ZJPH, B08PVN, 0373HX, B0NP6L, 03F364, 03922W, 02X173, 02WYQX, 02ND56, 0367GW, 0315P3, 02QMTL, 038W72, 03315L, 0358PV, 033JK7, 03128V, 032297.
989605353301, 989605353303, 989605387361
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.