TRANSDUCER L12-5 Transducer Probe
FDA Recall #Z-2402-2025 — Class III — July 3, 2025
Product Description
TRANSDUCER L12-5 Transducer Probe
Reason for Recall
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Recalling Firm
Philips Ultrasound, Inc — Reedsville, PA
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Devices
Product Quantity
171,322 units
Distribution
US Nationwide distribution.
Code Information
Model No. 989605408174; UDI: N/A; Serial No. B1D3VM.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated