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
Reported: May 20, 2015 Initiated: February 4, 2015 #Z-1611-2015
Product Description
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
Reason for Recall
Measurement values in the EMR may not accurately reflect the actual measurement value on the Synapse Cardiovascular clinical report.
Details
- Recalling Firm
- Fujifilm Medical Systems U.S.A., Inc.
- Units Affected
- 30 units
- Distribution
- Worldwide Distribution - US including CA, FL, IL, IN, MD, MI, MN, MO, NC, NY, OH, OR, PA, PR, TX, VA, WI Foreign: Canada
- Location
- Stamford, CT
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Fujifilm Medical Systems U.S.A., Inc.. Units affected: 30 units.
Why was this product recalled? ▼
Measurement values in the EMR may not accurately reflect the actual measurement value on the Synapse Cardiovascular clinical report.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 20, 2015. Severity: Moderate. Recall number: Z-1611-2015.
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