Z-2348-2025 Class III Ongoing
FDA device recall Z-2348-2025 was initiated by Philips Ultrasound, Inc on July 3, 2025 and is designated Class III. Reason for recall: To provide clarification and labelling to define the useful life of ultrasound transducers in the field. The recall status is ongoing. Affected quantity: 171,322 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 3, 2025
- Initiation Date
- July 3, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 171,322 units
Product Description
7.5MHZ Endo Transducer Probe
Reason for Recall
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Distribution Pattern
US Nationwide distribution.
Code Information
UDI: N/A; Serial No. F00262.