Recalls / —

—#214858

Product

3D6-2 Transducer Probe

FDA product code

IYN — System, Imaging, Pulsed Doppler, Ultrasonic

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K034003, K043535

Affected lot / code info

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

Why it was recalled

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

Root cause (FDA determination)

Device Design

Action the firm took

An URGENT Medical Device Correction Notice, dated 7/3/25, was mailed to consignees. This notice instructs consignees to locate all Philips Ultrasound transducers in their facility and enter their serial numbers into https://www.transducer.philips.com to obtain the manufacturing certificate for each of their devices. This certificate should be retained with its system documentation. Using the manufacturing certificate consignees are to calculate the useful life of their device. The expected useful life for Transesophageal transducers, X-Matrix transducers, and Lumify transducers is 5 years; The expected useful life for Endocavity transducers and Transcutaneous transducers is 7 years. If a transducer has exceeded its useful life, consignees are instructed to conduct transducer performance tests or contact Philips for guidance. Consignees are asked to complete and return the provided response form and circulate the recall notification to device users for their awareness. Consignees with any questions can contact Philips Customer Care Solutions Center at 1-800-722-9377.

Recalling firm

Firm

Philips Ultrasound, Inc

Address

1 Echo Dr, Reedsville, Pennsylvania 17084-8603

Distribution

Distribution pattern

US Nationwide distribution.

Timeline

Recall initiated

2025-07-03

Posted by FDA

2025-08-22

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #214858. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.