Recall Weekly
Low riskFDA DeviceClass III

Philips C9-4 ultrasound transducer recalled for labeling clarification on useful life

Philips Ultrasound, Inc. is clarifying labeling on the C9-4 ultrasound transducer to better define how long the device remains safe and effective in clinical use. This affects a very limited number of units distributed nationwide.

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

What to do

  1. Verify your transducer model number matches 989605365021
  2. Review updated labeling from Philips for guidance on device useful life
  3. Contact Philips if you have questions about your specific unit
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Philips C9-4 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
1 unit
Illnesses reported
None reported
Manufactured in
1 Echo Dr, Reedsville, PA, United States
Classification
Class III
Recall number
Z-1619-2026

In the FDA's words

Description
Philips C9-4 Ultrasound Transducer To provide clarification and labelling to define the useful life of ultrasound transducers in the field. Model No. 989605365021; UDI: N/A; Serial No. 033DZ4. Distribution: US Nationwide distribution. Affected quantity: 1 unit
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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