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Philips Ultrasound, Inc: Philips C9-4 Ultrasound Transducer

Medical DevicesSource: FDA (device) · Date: 2026-04-01

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Philips Ultrasound, Inc
Product
Philips C9-4 Ultrasound Transducer
Reason / hazard
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Classification
Class III
Status
Ongoing
Distribution / sold at
US Nationwide distribution.
Recall initiated
2025-09-05
Code info
Model No. 989605365021; UDI: N/A; Serial No. 033DZ4.
Product quantity
1 unit
Voluntary mandated
Voluntary: Firm initiated
City
Reedsville
State
PA
Country
United States
Event id
97643
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