FDA Enforcement
Class III
Ongoing
OMNI II TEE Transducer Probe
Recall: Z-2387-2025
·
Reported September 3, 2025
Enforcement
- Recall Number
- Z-2387-2025
- Event ID
- 97217
- Classification
- Class III
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Philips Ultrasound, Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- September 3, 2025
- Initiation Date
- July 3, 2025
- Classification Date
- August 22, 2025
- Address
- 1 Echo Dr, Reedsville, PA, 17084-8603, United States
Description
OMNI II TEE Transducer Probe
Reason
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Code Info
Model No. N/A; UDI: N/A; Serial No. 02DBYL, 02P8MV, 038CLG.
Distribution
US Nationwide distribution.
Quantity
171,322 units