Philips Ultrasound, Inc — OMNI III TEE Transducer Probe
⚠️ To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- July 3, 2025
US Nationwide distribution.
What's affected?
- Product
- OMNI III TEE Transducer Probe
- Lot code
- Model No. 989605440702, 21378A; UDI: (01)00884838067585(21)B1CW9T, (01)00884838067585(21)B201MC, (01)00884838067585(21)B1CW9Q, (01)00884838067585(21)B1MK5D, (01)00884838067585(21)B1MK5X, (01)00884838067585(21)B198WH, (01)00884838067585(21)B1MKD9, (01)00884838067585(21)B198V3, (01)00884838067585(21)B201JF, (01)00884838067585(21)B201Q0, (01)00884838067585(21)B1991G, (01)00884838067585(21)B17X87, (01)00884838067585(21)B1MKC3, (01)00884838067585(21)B201QF, (01)00884838067585(21)B2FW9F, (01)00884838067585(21)B198VV, (01)00884838067585(21)B07FFB, (01)00884838067585(21)B2FW8Z, (01)00884838067585(21)B201N8, (01)00884838067585(21)B34R1B, (01)00884838067585(21)B05DX2, (01)00884838067585(21)B0LYR8, (01)00884838067585(21)B201K2, (01)00884838067585(21)B198Z2, (01)00884838067585(21)B1991B; Serial No. B1CW9T, 02Y7HM, 02VTGK, B201MC, B1CW9Q, 037CHG, 03G8B1, 03G0BB, B1MK5D, B1MK5X, 02WH6F, 033ZLX, 033W7Z, 03CWJM, 02QK2L, B198WH, 038MJ6, 037F68, B1MKD9, 038GL7, 0344C9, B04LK2, B1991F, B198V3, B1FTDM, 0341PJ, B201JF, 037HLM, 035R8K, B201Q0, B1FTFZ, 02QCRQ, B1991G, 02JL01, B1MK2K, B17X87, 02JJ0T, 031LC8, B1MKC3, B201QF, B1990H, B19918, 03FZXM, 039JWQ, 035PYK, 03436F, B2FW9F, 039PCB, B1MK2F, 031HN7, 02P8GV, B198VV, 02H0WW, 039HQ2, B07FFB, B2FW8Z, 02WJBB, B201N8, 02VP8P, B34R1B, 02YK1Q, B19900, 039Q2L, B05DX2, 02YCFD, 02WCTB, 039PC3, 035V3H, B0LYR8, B201K2, 02PDT7, 032MLN, 035P8R, 038LT2, B0M32G, 03G4GG, B0X7N7, 038HV5, 032MMK, 02QGKV, 028PNR, B198Z2, 032FKW, B198ZV, 03GZ12, 03191G, B1991B, B198ZK, 03C04R, 030228.
Additional details
Model No. 989605440702, 21378A; UDI: (01)00884838067585(21)B1CW9T, (01)00884838067585(21)B201MC, (01)00884838067585(21)B1CW9Q, (01)00884838067585(21)B1MK5D, (01)00884838067585(21)B1MK5X, (01)00884838067585(21)B198WH, (01)00884838067585(21)B1MKD9, (01)00884838067585(21)B198V3, (01)00884838067585(21)B201JF, (01)00884838067585(21)B201Q0, (01)00884838067585(21)B1991G, (01)00884838067585(21)B17X87, (01)00884838067585(21)B1MKC3, (01)00884838067585(21)B201QF, (01)00884838067585(21)B2FW9F, (01)00884838067585(21)B198VV, (01)00884838067585(21)B07FFB, (01)00884838067585(21)B2FW8Z, (01)00884838067585(21)B201N8, (01)00884838067585(21)B34R1B, (01)00884838067585(21)B05DX2, (01)00884838067585(21)B0LYR8, (01)00884838067585(21)B201K2, (01)00884838067585(21)B198Z2, (01)00884838067585(21)B1991B; Serial No. B1CW9T, 02Y7HM, 02VTGK, B201MC, B1CW9Q, 037CHG, 03G8B1, 03G0BB, B1MK5D, B1MK5X, 02WH6F, 033ZLX, 033W7Z, 03CWJM, 02QK2L, B198WH, 038MJ6, 037F68, B1MKD9, 038GL7, 0344C9, B04LK2, B1991F, B198V3, B1FTDM, 0341PJ, B201JF, 037HLM, 035R8K, B201Q0, B1FTFZ, 02QCRQ, B1991G, 02JL01, B1MK2K, B17X87, 02JJ0T, 031LC8, B1MKC3, B201QF, B1990H, B19918, 03FZXM, 039JWQ, 035PYK, 03436F, B2FW9F, 039PCB, B1MK2F, 031HN7, 02P8GV, B198VV, 02H0WW, 039HQ2, B07FFB, B2FW8Z, 02WJBB, B201N8, 02VP8P, B34R1B, 02YK1Q, B19900, 039Q2L, B05DX2, 02YCFD, 02WCTB, 039PC3, 035V3H, B0LYR8, B201K2, 02PDT7, 032MLN, 035P8R, 038LT2, B0M32G, 03G4GG, B0X7N7, 038HV5, 032MMK, 02QGKV, 028PNR, B198Z2, 032FKW, B198ZV, 03GZ12, 03191G, B1991B, B198ZK, 03C04R, 030228.
What should I do?
Recommended action
Class III recall. Voluntary: Firm initiated Quantity affected: 171,322 units.
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