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Low riskFDA DeviceClass III

Philips OMNI II TEE Ultrasound Transducer recalled for useful life labeling clarification

Philips is clarifying the useful life labeling on certain OMNI II TEE Ultrasound Transducers to ensure healthcare facilities have accurate information about when these devices should be replaced. Two units with specific serial numbers (02P8MV and 02MH3J) were affected and distributed nationwide.

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

What to do

  1. If you operate a healthcare facility with this device, check if your transducer serial number matches the affected units
  2. Contact Philips for clarified labeling information and guidance on the device's useful life
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Philips OMNI II 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
2 units
Illnesses reported
None reported
Manufactured in
1 Echo Dr, Reedsville, PA, United States
Classification
Class III
Recall number
Z-1623-2026

In the FDA's words

Description
Philips OMNI II TEE Ultrasound Transducer To provide clarification and labelling to define the useful life of ultrasound transducers in the field. Model No. 989605440792; UDI: (01)00884838067660(21)02P8MV; Serial No. 02P8MV, 02MH3J. Distribution: US Nationwide distribution. Affected quantity: 2 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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