Class II — Potential Health Hazard

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

Change Healthcare Stratus Imaging PACS 1.4 and Stratus Imaging Share 1.4 Recalled by CHANGE HEALTHCARE CANADA COMPANY Due to Under certain circumstances, information from HL7 messages received...

Date: November 1, 2023
Company: CHANGE HEALTHCARE CANADA COMPANY
Status: Ongoing
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 CHANGE HEALTHCARE CANADA COMPANY directly.

Affected Products

Change Healthcare Stratus Imaging PACS 1.4 and Stratus Imaging Share 1.4, a component of Stratus Imaging PACS.

Quantity: 454

Why Was This Recalled?

Under certain circumstances, information from HL7 messages received by Stratus PACS/Imaging Share systems has been incorrectly associated with another patient's study.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About CHANGE HEALTHCARE CANADA COMPANY

CHANGE HEALTHCARE CANADA COMPANY has 12 total recalls tracked by RecallDetector.

Related Recalls

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