RecallHawk
Class III Recall

X7-2t Transducer Probe

Philips Ultrasound, Inc

Summary

The FDA issued a Class III for X7-2t Transducer Probe by Philips Ultrasound, Inc. Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field..

Details

Source

Device Recall

External ID

Z-2412-2025

Action Date

2025-09-03

Status

Ongoing

Category

device

Product Description

X7-2t Transducer Probe

Lot/Code Info: Model No. 989605414122, 989605414122, 989605414122, 989605414122, 989605414122, 989605361911, 989605414122, 989605414122, 989605350454, 989605461941, 989605461941, 989605414122, 989605414122, 989605438611, 989605438611, 989605438611, 989605438611, 989605414122, 989605414122, 989605438611, 989605414122, 989605414122, 989605461941, 989605350454, 989605461941, 989605350452, 989605461941, 989605461941, 989605414122, 989605414122, 989605361911, 989605414122, 989605414122, 989605414122, 989605414122, 989605414122, 989605361911, 989605414122, 989605414122, 989605414122, 989605414122, 989605414122, 989605414122, 989605461941, 989605461941, 989605461941, 989605461941, 989605461941, 989605414122, 989605414122, 989605350454, 989605461941, 989605414122, 989605414122, 989605414122, 989605414122, 989605414122, 989605414122, 989605438611, 989605414122, 989605461941, 989605438611, 989605414122, 989605414122, 989605414122, 989605414122, 989605461941, 989605414122, 989605414122, 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Quantity Affected: 171,322 units

Reason for Recall

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

Distribution

US Nationwide distribution.

Type: Voluntary: Firm initiated

Recall Initiated: 2025-07-03

Company

Philips Ultrasound, Inc

Reedsville, PA

Context & Analysis

This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.

This was one of 201 device recalls issued in the same week, part of 403 device-related FDA actions this month.

Philips Ultrasound, Inc has 111 FDA actions in our database, including 111 recalls.

Frequently Asked Questions

What is a Class III recall?

A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.

What should I do if I have this product?

Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Philips Ultrasound, Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.

How often does Philips Ultrasound, Inc have FDA actions?

Philips Ultrasound, Inc has 111 FDA actions in our database, including 111 recalls and 0 device clearances.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "Z-2412-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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