Health product recall

Synapse Picture Archiving And Communications Systems

Last updated

Summary

Product
Synapse Picture Archiving And Communications Systems
Issue
Medical devices - Performance issue
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products Lot or serial number Model or catalogue number
Synapse Picture Archiving And Communications Systems contact CHRISTIE INNOMED INC. SYNAPSE PACS VERSION 7.1.X SYNAPSE PACS VERSION 7.2.X SYNAPSE PACS VERSION 7.3.0X SYNAPSE PACS

Issue

Fujifilm has become aware that measurements on a secondary capture 2D image, that does not have pixel spacing in the DICOM header, when combined with a breast tomo series results in incorrect measurements. This issue affects Synapse PACS - versions 7.1.x, 7.2x and 7.3.0x. There have been no reported patient injuries associated with these issues.

Recall start date: January 30, 2024

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Radiology
Companies
Fujifilm Healthcare Americas Corporation
81 Hartwell Avenue, Suite 300, Lexington, Massachusetts, United States, 02421
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-75074

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