FDA-Device2025-09-03Class III
X5-1c Transducer Probe
Hazard
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Sold states
US Nationwide distribution.
Affected count
171,322 units
Manufactured in
1 Echo Dr, Reedsville, PA, United States
Products
X5-1c Transducer Probe
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2409-2025More Philips Ultrasound, Inc recalls
- FDA-Device2026-04-01Philips S5-2 Ultrasound Transducer recalled for clarification on useful life labeling
- FDA-Device2026-04-01Philips S4-1 Ultrasound Transducer recalled for clarification of useful life labeling
- FDA-Device2026-04-01Philips X3-1 ultrasound transducer recalled for labeling clarification on device lifespan
- FDA-Device2026-04-01Philips OMNI II TEE Ultrasound Transducer recalled for useful life labeling clarification
- FDA-Device2026-04-01Philips L17-5 Ultrasound Transducer recalled for labeling clarification on useful life
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