Philips Ultrasound, Inc: Medical Device Recall in 2025 - (Recall #: Z-2346-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.
Product Description:

3D6-2 Transducer Probe

Product Classification:

Class III

Date Initiated: July 3, 2025
Date Posted: September 3, 2025
Recall Number: Z-2346-2025
Event ID: 97217
Reason for Recall:

To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

Status: Ongoing
Product Quantity: 171,322 units
Code Information:

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

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated