Z-2367-2025 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
D2TCD 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. 989605412102, 989605438591; UDI: (01)00884838061361(21)B1N4HT, (01)00884838061361(21)B1N4J6, (01)00884838061361(21)B2L6QZ, (01)00884838061361(21)B2L6R0, (01)00884838061361(21)B2L6T9, (01)00884838061361(21)F01C9Y, (01)00884838061361(21)F074NX, (01)00884838061361(21)B2Q7FK, (01)00884838061361(21)F08MVZ, (01)00884838061361(21)B1NDJD, (01)00884838061361(21)B1N4JF, (01)00884838061361(21)B2L6TV, (01)00884838061361(21)F05Z77, (01)00884838061361(21)B2Q71X, (01)00884838061361(21)F0998F, (01)00884838061361(21)F0998J, (01)00884838061361(21)F09WC4, (01)00884838061361(21)F02H8Q, (01)00884838061361(21)F07JPJ, (01)00884838061361(21)F00LFM, (01)00884838061361(21)F00LFN, (01)00884838061361(21)B2Q7FT, (01)00884838061361(21)B2L6RJ, (01)00884838061361(21)B2L6RF, (01)00884838061361(21)B1N4KJ, (01)00884838061361(21)F067C1, (01)00884838061361(21)F068GD, (01)00884838061361(21)B1N4JR, (01)00884838061361(21)B2Q7FZ, (01)00884838061361(21)F01J0W, (01)00884838061361(21)B2Q71V, (01)00884838061361(21)B2Q71W, (01)00884838061361(21)B1N4HG, (01)00884838061361(21)F01J0R, (01)00884838061361(21)F0BBGN, (01)00884838061361(21)F0BFWZ, (01)00884838061361(21)F00436, (01)00884838061361(21)F00K75, (01)00884838061361(21)F00K76, (01)00884838061361(21)B2L6QD, (01)00884838061361(21)B2L6QW, (01)00884838061361(21)B2L6R1, (01)00884838061361(21)F04KMV, (01)00884838061361(21)F04KMW, (01)00884838061361(21)F04LKF, (01)00884838061361(21)B2L6TW, (01)00884838061361(21)B1N4JK, (01)00884838061361(21)B2L6T1, (01)00884838061361(21)B2L6TB, (01)00884838061361(21)B2L6TC, (01)00884838061361(21)B2Q7F3, (01)00884838061361(21)F08WZT, (01)00884838061361(21)F00LFK, (01)00884838061361(21)B1N4JC, (01)00884838061361(21)F0997G, (01)00884838061361(21)F044D8, (01)00884838061361(21)B1N4L6, (01)00884838061361(21)B2L6R6, (01)00884838061361(21)F04H4P, (01)00884838061361(21)F02DZ1, (01)00884838061361(21)B1N4HC, (01)00884838061361(21)F05Y8G, (01)00884838061361(21)B1N4JN, (01)00884838061361(21)B1N4JP, (01)00884838061361(21)B2Q71C, (01)00884838061361(21)B2Q71R, (01)00884838061361(21)F02MCH, (01)00884838061361(21)B1N4HN, (01)00884838061361(21)B1N4JZ, (01)00884838061361(21)B1N4K1, (01)00884838061361(21)B2Q7F8, (01)00884838061361(21)F00433, (01)00884838061361(21)F04CR4, (01)00884838061361(21)B2L6RL, (01)00884838061361(21)B2Q722, (01)00884838061361(21)F0043C, (01)00884838061361(21)F0997H, (01)00884838061361(21)F04FX3, (01)00884838061361(21)B2L6RB, (01)00884838061361(21)B1N4L7, (01)00884838061361(21)B1N4L9, (01)00884838061361(21)B2Q7FH, (01)00884838061361(21)F04ZZM, (01)00884838061361(21)F04ZZP, (01)00884838061361(21)F04ZZQ, (01)00884838061361(21)F0BR74, (01)00884838061361(21)F0316R, (01)00884838061361(21)F032WT, (01)00884838061361(21)F08RMV, (01)00884838061361(21)B2L6QG, (01)00884838061361(21)B2L6QM, (01)00884838061361(21)B2Q71H, (01)00884838061361(21)B2Q71T, (01)00884838061361(21)F09WC5, 010088483806136121F023HC, (01)00884838061361(21)B1N4LC, (01)00884838061361(21)B2Q270, (01)00884838061361(21)B2Q6XW, (01)00884838061361(21)F0006C, (01)00884838061361(21)F06FFP, (01)00884838061361(21)F09WC3, (01)00884838061361(21)B1N4KM, (01)00884838061361(21)B2Q71Y, (01)00884838061361(21)B2Q703, (01)00884838061361(21)B2Q6XL, (01)00884838061361(21)B2Q6XM, (01)00884838061361(21)F04ZZN, (01)00884838061361(21)B1N4J0, (01)00884838061361(21)F00LFP, (01)00884838061361(21)F01J0Q, 010088483806136121F025TJ, (01)00884838061361(21)B2Q702, (01)00884838061361(21)B1N4JG, (01)00884838061361(21)F09YQ5, (01)00884838061361(21)B2Q704, (01)00884838061361(21)F0BR76, (01)00884838061361(21)F04650, (01)00884838061361(21)F092BL, (01)00884838061361(21)F0BBGM, (01)00884838061361(21)F06QKW; Serial No. B1N4HT, B1N4J6, B2L6QZ, B2L6R0, B2L6T9, F01C9Y, F074NX, B2Q7FK, F08MVZ, B1NDJD, B2L6R5, B1N4JF, B2L6TV, F05Z77, B2Q71X, F0998F, F0998J, F09WC4, F02H8Q, F07JPJ, F00LFM, F00LFN, B2Q7FT, B2L6RJ, B2L6RF, B1N4KJ, F067C1, F068GD, B1N4JR, B2Q7FZ, F01J0W, B2Q71V, B2Q71W, B1N4HG, F01J0R, F0BBGN, F0BFWZ, F00436, F00K75, F00K76, B2L6QD, B2L6QW, B2L6R1, F04KMV, F04KMW, F04LKF, B2L6TW, B1N4JK, B2L6T1, B2L6TB, B2L6TC, B2Q7F3, F08WZT, F00LFK, B13LLG, B1N4JC, F0997G, F044D8, B1N4L6, B2L6R6, F04H4P, F02DZ1, B1N4HC, F05Y8G, B1N4JN, B1N4JP, B2Q71C, B2Q71R, F02MCH, B1N4HN, B1N4JZ, B1N4K1, B2Q7F8, F00433, F04CR4, B2L6RL, B2Q722, F0043C, F0997H, F04FX3, B2L6RB, B1N4L7, B1N4L9, B2Q7FH, F04ZZM, F04ZZP, F04ZZQ, F0BR74, B13LLX, B13LKY, F0316R, F032WT, F08RMV, B2L6QG, B2L6QM, B2Q71H, B2Q71T, F09WC5, F023HC, B1N4LC, B2Q270, B2Q6XW, F0006C, F06FFP, F09WC3, B1N4KM, B2Q71Y, B2Q703, B2Q6XL, B2Q6XM, F04ZZN, B13LL8, B1N4J0, F00LFP, F01J0Q, F025TJ, B2Q702, B1N4JG, B13LLW, F09YQ5, B2Q704, F0BR76, F04650, F092BL, F0BBGM, F06QKW.