Fujifilm Synapse PACS, Software versions: 4.0.xxx, 4.1.xxx, version 4.2.xxx, version 4.3.xxx Medical imaging and information management system, SYNAPSE allows the archiving and distribution of image information from all modalities
Reported: October 19, 2016 Initiated: September 15, 2016 #Z-0073-2017
Product Description
Fujifilm Synapse PACS, Software versions: 4.0.xxx, 4.1.xxx, version 4.2.xxx, version 4.3.xxx Medical imaging and information management system, SYNAPSE allows the archiving and distribution of image information from all modalities
Reason for Recall
Image data for a patients image may not be correct
Details
- Recalling Firm
- Fujifilm Medical Systems U.S.A., Inc.
- Units Affected
- 251 units
- Distribution
- US Nationwide Distribution.
- Location
- Stamford, CT
Frequently Asked Questions
What product was recalled? ▼
Fujifilm Synapse PACS, Software versions: 4.0.xxx, 4.1.xxx, version 4.2.xxx, version 4.3.xxx Medical imaging and information management system, SYNAPSE allows the archiving and distribution of image information from all modalities. Recalled by Fujifilm Medical Systems U.S.A., Inc.. Units affected: 251 units.
Why was this product recalled? ▼
Image data for a patients image may not be correct
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 19, 2016. Severity: Moderate. Recall number: Z-0073-2017.
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