CHANGE HEALTHCARE CANADA COMPANY: Medical Device Recall in 2023 - (Recall #: Z-0551-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: November 1, 2023

Date Posted: December 20, 2023

Recall Number: Z-0551-2024

Event ID: 93451

Reason for Recall:

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

Status: Ongoing

Product Quantity: 454

Code Information:

Version 1.4, UDI (01)17540262160093(10)010400

Distribution Pattern:

US Nationwide distribution. There was no military/government distribution.

Voluntary or Mandated:

Voluntary: Firm initiated