Z-2371-2025 Class III Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- September 3, 2025
- Initiation Date
- July 3, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 171,322 units
Product Description
L11-3 Transducer Probe
Reason for Recall
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Distribution Pattern
US Nationwide distribution.
Code Information
Model No. 989605388251, 989605400511, 989605400513, 989605440762; UDI: (01)00884838067639(21)B1Y3CY, (01)00884838067967(21)F08RH4, (01)00884838067639(21)B1Y33W, (01)00884838067967(21)B1X2F6, (01)00884838067639(21)B1RY1G, (01)00884838067639(21)B1RXQ9, (01)00884838067639(21)B305V2, (01)00884838067967(21)B2H0PB, (01)00884838067967(21)B2PQ4H, (01)00884838067967(21)B2GZFN, (01)00884838067967(21)B2PV1V, (01)00884838067967(21)B2PTWK, (01)00884838067967(21)B2PMRG, (01)00884838067967(21)B2PMR8, (01)00884838067967(21)F08MFD, (01)00884838067967(21)B20DKD, (01)00884838067967(21)B24Q2T, (01)00884838067967(21)B27J4W, (01)00884838067967(21)B32RQX, (01)00884838067639(21)B1Y2DB, (01)00884838067967(21)B20KMM, (01)00884838067967(21)B1WTXZ, (01)00884838067967(21)B3YNDY, (01)00884838067639(21)B1Y3FG, (01)00884838067967(21)B1RMX9, (01)00884838067639(21)B2NN5M, (01)00884838067967(21)B2ZV3F, (01)00884838067639(21)B1Y3DR, (01)00884838067967(21)B24Q31, (01)00884838067967(21)F0GJN2, (01)00884838067967(21)B2PPZ7; Serial No. B1Y3CY, B14GMY, F08RH4, B1Y33W, B1X2F6, B1RY1G, B1RXQ9, B305V2, B2H0PB, B2PQ4H, B2GZFN, B2PV1V, B2PTWK, B2PMRG, B2PMR8, F08MFD, B19HW9, B20DKD, B24Q2T, B27J4W, B1CDP5, B32RQX, B19R86, B1Y2DB, B20KMM, B19H1P, B1WTXZ, B3YNDY, B1Y3FG, B0B20T, B1RMX9, B2NN5M, B1DCBR, B2ZV3F, B1Y3DR, B24Q31, F0GJN2, B2PPZ7.