# FDA recall Z-0551-2024

> **CHANGE HEALTHCARE CANADA COMPANY** · Class II · device recall initiated 2023-11-01.

## Product

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

## 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.

## Distribution

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

## Key facts

- **Recall number:** Z-0551-2024
- **Recalling firm:** CHANGE HEALTHCARE CANADA COMPANY
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-11-01
- **Report date:** 2023-12-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Richmond, N/A, Canada

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0551-2024

## Citation

> AI Analytics. FDA recall Z-0551-2024. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-0551-2024. Source: US FDA. Licensed CC0.

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