Device product
C9-5ec Transducer Probe
Z-2365-2025
Product summary
- Event
- Event 97217
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 171,322 units
- Official record key
device-enforcement:Z-2365-2025
Official wording
Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Code information: Model No. 989605387351, 989605440802; UDI: (01)00884838067677(21)B1X88J, (01)00884838067677(21)B264HW, (01)00884838067677(21)B36JG7, (01)00884838067677(21)B29HQQ, (01)00884838067677(21)B264LH, (01)00884838067677(21)B2X78L, (01)00884838067677(21)B3055N, (01)00884838067677(21)B284J2, (01)00884838067677(21)F06LP2, (01)00884838067677(21)B1K3BP, (01)00884838067677(21)B32262, (01)00884838067677(21)B36JHC, (01)00884838067677(21)B2J631, (01)00884838067677(21)B3224T, (01)00884838067677(21)F02K00, (01)00884838067677(21)B2X710, (01)00884838067677(21)B3MDX4, (01)00884838067677(21)B1LJYQ, (01)00884838067677(21)B36JPK, (01)00884838067677(21)F02R0G, (01)00884838067677(21)B3225C, (01)00884838067677(21)B1M76Q, (01)00884838067677(21)B1X891, (01)00884838067677(21)B1X8BM, (01)00884838067677(21)B1X8CY, (01)00884838067677(21)B1X8FQ, (01)00884838067677(21)B201N5, (01)00884838067677(21)B201N7, (01)00884838067677(21)B29JBL, (01)00884838067677(21)B2X71C, (01)00884838067677(21)B2X7BN, (01)00884838067677(21)B29HTL, (01)00884838067677(21)B2X71M, (01)00884838067677(21)F02LY6, (01)00884838067677(21)B29HX3, (01)00884838067677(21)F04F0Z, (01)00884838067677(21)F0B377, (01)00884838067677(21)F0BBHC, (01)00884838067677(21)B1FRLC, (01)00884838067677(21)F0568P, (01)00884838067677(21)B1M6XC, (01)00884838067677(21)B1M6X7, (01)00884838067677(21)B1M6Z0, (01)00884838067677(21)B1M6W4, (01)00884838067677(21)B264NN, (01)00884838067677(21)B32288, (01)00884838067677(21)B1M733, (01)00884838067677(21)B1X8C6, (01)00884838067677(21)B3225P, (01)00884838067677(21)B32249, (01)00884838067677(21)B23K8G, (01)00884838067677(21)F08HQ3, (01)00884838067677(21)B1M6MQ, (01)00884838067677(21)B1M6WV, (01)00884838067677(21)B29HNP, (01)00884838067677(21)B29HT7, (01)00884838067677(21)B29HVW, (01)00884838067677(21)B1M6XK, (01)00884838067677(21)F04Y2Q, (01)00884838067677(21)B2J65X, (01)00884838067677(21)B2X7B9, (01)00884838067677(21)B23K8F, (01)00884838067677(21)B3226Y, (01)00884838067677(21)B284H7, (01)00884838067677(21)B29JDJ, (01)00884838067677(21)B23KG1, (01)00884838067677(21)B2PFMP, (01)00884838067677(21)B2X719, (01)00884838067677(21)F0BFKM, (01)00884838067677(21)B1M6X5, (01)00884838067677(21)B29J68, (01)00884838067677(21)B1LJZ3, (01)00884838067677(21)B32275, (01)00884838067677(21)F04F12, (01)00884838067677(21)B264PH, (01)00884838067677(21)B29HVV, (01)00884838067677(21)B1M72G, (01)00884838067677(21)F04F0X, (01)00884838067677(21)F02CZ8, (01)00884838067677(21)F09X1T, (01)00884838067677(21)F0B54N, (01)00884838067677(21)B3227J, (01)00884838067677(21)B1X88Q, (01)00884838067677(21)B3225H, (01)00884838067677(21)F029M0, (01)00884838067677(21)F06B2W, (01)00884838067677(21)F0997T; Serial No. B1X88J, B264HW, B36JG7, B29HQQ, B1LJVM, B264LH, B2X78L, B3055N, B284J2, F06LP2, B16YMW, B1K3BP, B32262, B36JHC, B2J631, B3224T, F02K00, B2X710, B2X720, B3MDX4, B1LJYQ, B36JPK, F02R0G, B3225C, B1M76Q, B1X891, B1X8BM, B1X8CY, B1X8FQ, B201N5, B201N7, B29JBL, B2X71C, B2X7BN, B29HTL, B2X71M, F02LY6, B29HX3, F04F0Z, F0B377, F0BBHC, B1FRLC, B1K3GM, F0568P, B1M6XC, B16YM7, B1M6X7, B1M6Z0, B1M6W4, B264NN, B32288, B1M733, B1X8C6, B3225P, B32249, B23K8G, F08HQ3, F02JZZ, B1M6MQ, B1M6WV, B29HNP, B29HT7, B29HVW, B1M6XK, F04Y2Q, B2J65X, B2X7B9, B16YKR, B23K8F, B3226Y, B284H7, B29JDJ, B23KG1, B2PFMP, B2X719, F0BFKM, B1M6X5, B29J68, B1LJZ3, B16YG5, B32275, F04F12, B264PH, B1K3J5, B1K3CC, B29HVV, B16YGZ, B1M72G, B1K3G0, F04F0X, F02CZ8, F09X1T, F0B54N, B264LY, B1K3J8, B3227J, B1K3M8, B1X88Q, B3225H, B1LJWQ, F029M0, F06B2W, F0997T.
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.