medical Class II Updated 2021-06-09

Fujifilm Medical Systems U.S.A., Inc. recalls Synapse Cardiovascular (Synapse CV). Software Versions: 6.

Recalled Product

Synapse Cardiovascular (Synapse CV). Software Versions: 6.0 to 6.2.1 The Synapse Cardiovascular image is a management and reporting system


Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Software Versions: 6.0 to 6.2.1
View official government recall

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