FDA Enforcement
Class III
Ongoing
Philips X7-2 Ultrasound Transducer
Recall: Z-1628-2026
·
Reported April 1, 2026
Enforcement
- Recall Number
- Z-1628-2026
- 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 X7-2 Ultrasound Transducer
Reason
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Code Info
Model No. 989605388121, 989605347571, 989605347573; UDI: (01)00884838061729(21)0344RZ; Serial No. 03FG1T, 031LM2, 032Q7G, 0344RZ, 033VM9.
Distribution
US Nationwide distribution.
Quantity
5 units