medical LOW RISK Updated 2026-04-01

Philips Ultrasound, Inc recalls Philips OMNI II TEE Ultrasound Transducer

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Recalled Product

Philips OMNI II TEE Ultrasound Transducer

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Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Model No. 989605440792; UDI: (01)00884838067660(21)02P8MV; Serial No. 02P8MV, 02MH3J.

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

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View official government recall

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