FDA-Device2021-06-09Class II
Synapse Cardiovascular (Synapse CV). Software Versions: 6.0 to 6.2.1 The Synapse Cardiovascular image is a management and reporting system
Fujifilm Medical Systems U.S.A., Inc.
Hazard
Software versions 6.0.4 to 6.2.1 using Advanced Reporting -possibility that a previously assigned internal patient database ID can be reused for a new patient. It was discovered that this value does not increase when a patient merge activity is executed in a specific sequence
Sold states
Worldwide distribution - US Nationwide distribution and the countries of Canada, Bermuda, Israel, Hadassah Medical Center.
Affected count
44 US and 4 OUS
Manufactured in
81 Hartwell Ave Ste 300, Lexington, MA, United States
Products
Synapse Cardiovascular (Synapse CV). Software Versions: 6.0 to 6.2.1 The Synapse Cardiovascular image is a management and reporting system
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1775-2021Don't want to check this manually?
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