3D6-2 Transducer Probe

FDA Recall #Z-2346-2025 — Class III — July 3, 2025

Recall #Z-2346-2025 Date: July 3, 2025 Classification: Class III Status: Ongoing

Product Description

3D6-2 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. 989605440872, 8500-2032-01; UDI: N/A; Serial No. 031XK6, 02VF0G, 02M3N3, 031VQT, 03GKDF, 02TWD3, 02NDCL, 02CBD4, 02KWQ9.

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated