FDA recall Z-1618-2026
Philips Ultrasound, Inc · Class III · device
Product
Philips 3D6-2 Ultrasound Transducer
Reason for recall
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Distribution
US Nationwide distribution.
Key facts
- Status
- Ongoing
- Initiation date
- 2025-09-05
- Report date
- 2026-04-01
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Reedsville, PA, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1618-2026