Synapse PACS - Version 7.1.000US recall
Synapse PACS - Version 7.1.000US
Why was Synapse PACS - Version 7.1.000US recalled?
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 should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Software Version: 7.1.000US, UDI: (01)854904006008(10)0701000US
- Product
- Synapse PACS - Version 7.1.000US
- Recalling firm
- FUJIFILM Healthcare Americas Corporation
- Quantity
- 3 Units (3 US)
- Distribution
- Worldwide distribution - US Nationwide, including Puerto Rico and the countries of Australia, Belgium, Brazil, Canada, Colombia, Ecuador, France, Germany, India, Italy, Mexico, Namibia, Netherlands, Portugal, Qatar, Spain, Thailand, Turkey, UAE, United Kingdom.
- Recall date
- March 13, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)