FDA recall Z-0551-2024

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

Status

Ongoing

Initiation date

2023-11-01

Report date

2023-12-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

Richmond, N/A, Canada

Primary source

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