← FDA ENFORCEMENT
Z-1624-2026Class III

Philips Ultrasound, Inc

Recalling firm
Philips Ultrasound, Inc
Product type
Device
Status
Ongoing
Report date
2026-04-01
Distribution
US Nationwide distribution.
Firm state
PA
Product quantity
75 units
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Documentation & Change Control
Reason for recall

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

Product description

Philips OMNI III TEE Ultrasound Transducer

Code / lot 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.

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.