Synapse Picture Archiving And Communications Systems
Last updated
Summary
Product
Synapse Picture Archiving And Communications Systems
Issue
Medical devices - Performance
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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