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Low riskFDA DeviceClass III

Philips Mini Multi TEE Ultrasound Transducer recalled for labeling clarification on useful life

Philips is clarifying labeling on certain Mini Multi TEE Ultrasound Transducers to better define when these devices should no longer be used in clinical settings. The affected units may lack clear guidance on their useful lifespan, which could affect safe operation.

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

What to do

  1. If you operate one of the affected models (989605439241, 989605439242, or 21381A), contact Philips for updated labeling information.
  2. Review the serial numbers listed in the recall notice to determine if your unit is affected.
  3. Do not discard the device; await instructions from Philips on next steps.
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Philips Mini Multi 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
11 units
Illnesses reported
None reported
Manufactured in
1 Echo Dr, Reedsville, PA, United States
Classification
Class III
Recall number
Z-1622-2026

In the FDA's words

Description
Philips Mini Multi TEE Ultrasound Transducer To provide clarification and labelling to define the useful life of ultrasound transducers in the field. Model No. 989605439241, 989605439242, 21381A; UDI: (01)00884838067547(21)B093BQ, (01)00884838067547(21)B0988T, (01)00884838067547(21)02P6MY, (01)00884838067547(21)039M2Q, (01)00884838067547(21)0319CQ, (01)00884838067547(21)B01639; Serial No. 02GXR0, B093BQ, B0988T, 02P6MY, 039M2Q, 0341YT, 0319CQ, 028NZW, 02H0L8, B01639, 039M2M. Distribution: US Nationwide distribution. Affected quantity: 11 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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