FDA-Device2026-04-01Class IIIMISBRANDING

Philips 3D6-2 Ultrasound Transducer recalled for clarification on useful life labeling

EXPIRATION DATE ERRORNationwide distributionMedical devices

What this means

Philips is clarifying and updating labeling on certain 3D6-2 Ultrasound Transducers to better define their useful life in the field. This affects a limited number of units distributed nationwide. No injuries have been reported.

  • If you operate one of the affected transducers, contact Philips for updated labeling or guidance
  • Review the serial numbers and UDI codes listed in the recall notice to determine if your unit is affected
The agency's original wording
Hazard

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

Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution.
Affected count
17 units
Manufactured in
1 Echo Dr, Reedsville, PA, United States
Products
Philips 3D6-2 Ultrasound Transducer

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1618-2026

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