FUJIFILM Healthcare Americas Corporation 2024-03-13 Health serious FDA
Health · FDA · Recall #FDA-Z-1271-2024
Synapse PACS - Version 7.2.100 Recall
Issued March 13, 2024 · FUJIFILM Healthcare Americas Corporation
In March 2024, FUJIFILM Healthcare Americas Corporation recalled the Synapse PACS - Version 7.2.100, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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.
What you should do
- 1 Stop using Synapse PACS - Version 7.2.100 right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact FUJIFILM Healthcare Americas Corporation to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- FUJIFILM Healthcare Americas Corporation
- Category
- Health
- Recall date
- March 13, 2024
- Units affected
- Not reported
- Sold at
- Worldwide distribution - US Nationwide, including Puerto Rico and the countries of Australia, Belgium, Brazil, Canada, Colombia, Ecuador, F
- Recall number
- FDA-Z-1271-2024
- Made in
- United States
- Issuing agency
- FDA
In context
- FUJIFILM Healthcare Americas Corporation has 2 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 737th Health recall we've logged in 2024.