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Recall Observatory FDA recall evidence

Device product

Change Healthcare Radiology Solutions, software versions 14.0, 14.1, and 14.2 Medical image and information management software.

Z-0237-2024

October 12, 2023

Class II

Product summary

Firm
CHANGE HEALTHCARE CANADA COMPANY
Event
Event 93259
Status
Ongoing
Classification
Class II
Quantity
282 units
Official record key
device-enforcement:Z-0237-2024

Official wording

Reason: Change Healthcare has identified a software issue where Change Healthcare Radiology Solutions 14.0, 14.1, and 14.2 may not update records in external applications.

Code information: UDI/DI 17540262030020

Distribution pattern: US, Canada, Ireland, Saudi Arabia, France, UK

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    software issue