Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Philips Ultrasound Recalled by Philips Ultrasound, Inc. Due to Philips Healthcare has discovered a problem in the...

Date: May 15, 2015
Company: Philips Ultrasound, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Philips Ultrasound, Inc. directly.

Affected Products

Philips Ultrasound, Model Q-Station, with software version 3 or higher, Catalog number: 795088; Part Number: 989605382391 Q-Station is application software intended to manage, view, analyze, and report qualitative and quantitative image data from ultrasound exams. It is designed to host optional advanced analysis applications via QLAB integration and provide integrated tools that allow users to manually assess and score cardiac wall motion and export images and / or exams and reports. Q-Station can view DICOM images of non-ultrasound images such as CT, MR, NM, CR, MG, XA, PET, RT and X-Ray modalities for reference viewing. It support connectivity to ultrasound systems, PACS and other DICOM storage repositories.

Quantity: 125 units (30 in US and 95 international)

Why Was This Recalled?

Philips Healthcare has discovered a problem in the Philips Ultrasound Q-Station version 3.0 or higher that could result in measurements from a study (Structured Report) to be appended to subsequent studies for other patients.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Philips Ultrasound, Inc.

Philips Ultrasound, Inc. has 17 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report