FDA Enforcement
Class III
Ongoing
Philips S5-2 Ultrasound Transducer
Recall: Z-1626-2026
·
Reported April 1, 2026
Enforcement
- Recall Number
- Z-1626-2026
- Event ID
- 97643
- Classification
- Class III
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Philips Ultrasound, Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- April 1, 2026
- Initiation Date
- September 5, 2025
- Classification Date
- March 24, 2026
- Address
- 1 Echo Dr, Reedsville, PA, 17084-8603, United States
Description
Philips S5-2 Ultrasound Transducer
Reason
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Code Info
Model No. 989605368393; (01)00884838064638(21)B0C824; Serial No. B0C824.
Distribution
US Nationwide distribution.
Quantity
1 unit