FDA recall Z-1623-2026
Philips Ultrasound, Inc · Class III · device
Product
Philips OMNI II TEE 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-1623-2026