Device product
FujiMedical Synapse Cardiovascular I ProSolv CardioVascular. A picture Archiving and Communication System Software versions: Synapse Cardiovascular v4.0.8 Synapse Cardiovascular v4.0.8 SR1
Z-1611-2015
Product summary
- Event
- Event 70891
- Status
- Terminated
- Classification
- Class II
- Quantity
- 30 units
- Official record key
device-enforcement:Z-1611-2015
Official wording
Reason: Measurement values in the EMR may not accurately reflect the actual measurement value on the Synapse Cardiovascular clinical report.
Code information: Software versions: Synapse Cardiovascular v4.0.8 Synapse Cardiovascular v4.0.8 SR1
Distribution pattern: Worldwide Distribution - US including CA, FL, IL, IN, MD, MI, MN, MO, NC, NY, OH, OR, PA, PR, TX, VA, WI Foreign: Canada
Derived failure modes
-
Unknown
Measurement values in the EMR may not accurately reflect the actual measurement value on the Synapse Cardiovascular clinical report.