Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0551-2024 — Change Healthcare Stratus Imaging PACS 1.4 and Stratus Imaging Share 1.4, a component of Stratus Imaging PACS.

U.S. FDA — Device Enforcement · Canada · 2023-11-01 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0551-2024
Date of alert
2023-11-01
Country / jurisdiction
Canada
Risk level
Class II
Risk type
recall
Brand
CHANGE HEALTHCARE CANADA COMPANY
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
17540262160093
Reported risk: Under certain circumstances, information from HL7 messages received by Stratus PACS/Imaging Share systems has been incorrectly associated with another patient's study.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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