Synapse PACS - Version 7.2.000
Reported: March 13, 2024 Initiated: January 10, 2024 #Z-1270-2024
Product Description
Synapse PACS - Version 7.2.000
Reason for Recall
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.
Details
- Recalling Firm
- FUJIFILM Healthcare Americas Corporation
- Units Affected
- 19 Units (7 US, 12 OUS)
- 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.
- Location
- Lexington, MA
Frequently Asked Questions
What product was recalled? ▼
Synapse PACS - Version 7.2.000. Recalled by FUJIFILM Healthcare Americas Corporation. Units affected: 19 Units (7 US, 12 OUS).
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 13, 2024. Severity: Moderate. Recall number: Z-1270-2024.
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