Class IIIReported 2026-04-01

Philips OMNI III TEE Ultrasound Transducer

Recalled by Philips Ultrasound, Inc

Reason for Recall

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Recall Number

Z-1624-2026

Classification

Class III

Status

Ongoing

Category

device

Initiated

2025-09-05

Reported

2026-04-01

Distribution

US Nationwide distribution.

Code Info

Model No. 989605440701, 989605440702, 989605440772, 989803001561; UDI: (01)00884838067585(21)02ZTTT, (01)00884838067585(21)B0X7MD, (01)00884838067585(21)02VWNV, (01)00884838067585(21)02JQPG, (01)00884838067585(21)02PCMT, (01)00884838067585(21)0341PG, (01)00884838067585(21)02QLMQ, (01)00884838067585(21)B0JFCN, (01)00884838067585(21)03C009, (01)00884838067585(21)02Y7HM, (01)00884838067585(21)02VTGK, (01)00884838067585(21)037CHG, (01)00884838067585(21)03G0BB, (01)00884838067585(21)02WH6F, (01)00884838067585(21)02QK2L, (01)00884838067585(21)037F68, (01)00884838067585(21)0344C9, (01)00884838067585(21)037HLM, (01)00884838067646(21)035R8K, (01)00884838067585(21)02JJ0T, (01)00884838067585(21)031LC8, (01)00884838067585(21)039JWQ, (01)00884838067585(21)03436F, (01)00884838067585(21)039PCB, (01)00884838067585(21)02P8GV, (01)00884838067585(21)B07FFB, (01)00884838067585(21)03F770, (01)00884838067585(21)0319LX, (01)00884838067585(21)02DG0D, (01)00884838067585(21)B0JF93, (01)00884838067585(21)03C7Q0, (01)00884838067585(21)039Q2L, (01)00884838067585(21)02YCFD, (01)00884838067585(21)B05DX2, (01)00884838067585(21)02WCTB, (01)00884838067585(21)039PC3, (01)00884838067585(21)035V3H, (01)00884838067585(21)038DX2, (01)00884838067585(21)B0LYR8, (01)00884838067585(21)02CGWH, (01)00884838067585(21)032MLN, (01)00884838067585(21)038LT2, (01)00884838067585(21)03G4GG, (01)00884838067585(21)03435X, (01)00884838067585(21)032MMK, (01)00884838067585(21)B0JFDK, (01)00884838067585(21)02WMD4, (01)00884838067585(21)02JP4Z, (01)00884838067585(21)031LCH, (01)00884838067585(21)02JJ6T, (01)00884838067585(21)039JWV, (01)00884838067585(21)035YQG, (01)00884838067585(21)03C04R, (01)00884838067585(21)02DCH7, (01)00884838067585(21)02D9TH, (01)00884838067585(21)035Q9M, (01)00884838067585(21)031CDK, (01)00884838067585(21)0379BH; Serial No. 02ZTTT, 02DFBP, B0X7MD, 039MMD, 02VWNV, 02JQPG, 02PCMT, 0341PG, 02GR5B, 035PWZ, 02QLMQ, B0JFCN, 03CVTB, 03C009, 02Y7HM, 02VTGK, 037CHG, 03G0BB, 02WH6F, 02QK2L, 038MJ6, 037F68, 038GL7, 0344C9, 037HLM, 035R8K, 02JL01, 02JJ0T, 031LC8, 039JWQ, 035PYK, 03436F, 039PCB, 031HN7, 02P8GV, 039HQ2, B07FFB, 03F770, 035Q9P, 0319LX, 02DG0D, B0JF93, 03C7Q0, 039Q2L, 02YCFD, B05DX2, 02WCTB, 039PC3, 035V3H, 038DX2, B0LYR8, 02CGWH, 032MLN, 035P8R, 038LT2, 03G4GG, 03435X, 032MMK, 02QGKV, B0JFDK, 02VN40, 032FKW, 02WMD4, 02JP4Z, 031LCH, 02JJ6T, 039JWV, 035YQG, 03C04R, 03C6ZH, 02DCH7, 02D9TH, 035Q9M, 031CDK, 0379BH.

Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.