FDA-Device2026-04-01Class III

Philips S5-2 Ultrasound Transducer

Philips Ultrasound, Inc
Hazard
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Sold states
US Nationwide distribution.
Affected count
1 unit
Manufactured in
1 Echo Dr, Reedsville, PA, United States
Products
Philips S5-2 Ultrasound Transducer

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1626-2026

Original summary

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

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