Recall Weekly
Low riskFDA DeviceClass III

Philips S5-2 Ultrasound Transducer recalled for clarification on useful life labeling

Philips Ultrasound, Inc. is providing clarification and updated labeling for the S5-2 Ultrasound Transducer to define its useful life in the field. This affects a limited number of units distributed nationwide.

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

What to do

  1. Verify your Philips S5-2 transducer serial number (B0C824) against the recall notice
  2. Contact Philips Ultrasound, Inc. for updated labeling and guidance on useful life
  3. Review updated documentation before continued use in clinical settings
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Philips S5-2 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-1626-2026

In the FDA's words

Description
Philips S5-2 Ultrasound Transducer To provide clarification and labelling to define the useful life of ultrasound transducers in the field. Model No. 989605368393; (01)00884838064638(21)B0C824; Serial No. B0C824. 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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