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Low riskFDA DeviceClass III

Philips OMNI III TEE Ultrasound Transducer recalled for labeling clarification on useful life

Philips is clarifying and updating labeling on certain OMNI III TEE ultrasound transducers to better define their useful life in the field. This is a precautionary measure affecting 75 units distributed nationwide.

From the FDA notice · Read the official notice ↗ · All Philips recalls

What to do

  1. Check your device serial number against the recalled list
  2. Contact Philips or your equipment supplier for updated labeling
  3. Review the manufacturer's guidance on transducer useful life
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Philips OMNI III TEE Ultrasound Transducer
Sold in
Nationwide
Made for
All ages (0 months and older)

This recall covers 11 products — see all of them.

Details

Units affected
75 units
Illnesses reported
None reported
Manufactured in
1 Echo Dr, Reedsville, PA, United States
Classification
Class III
Recall number
Z-1624-2026

In the FDA's words

Description
Philips OMNI III TEE Ultrasound Transducer To provide clarification and labelling to define the useful life of ultrasound transducers in the field. 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. Distribution: US Nationwide distribution. Affected quantity: 75 units
Hazard
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

11 products in this recall

Philips ultrasound transducers recalled for unclear useful-life labeling

Philips is recalling 11 ultrasound transducer models to clarify and update labeling that defines how long these devices are expected to remain in use. The recall was filed for clarification, and no injuries have been reported.

The agency lists each product separately. Check every one you might have.

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