Fujifilm Synapse Cardiovascular I ProSolv CardioVascular Synapse Cardiovascular v4.0.8 Synapse Cardiovascular v4.0.8 SR1 Intended Use: Picture Archiving and Communication System Computer, Diagnostic, Programmable
Reported: May 20, 2015 Initiated: February 4, 2015 #Z-1612-2015
Product Description
Fujifilm Synapse Cardiovascular I ProSolv CardioVascular Synapse Cardiovascular v4.0.8 Synapse Cardiovascular v4.0.8 SR1 Intended Use: Picture Archiving and Communication System Computer, Diagnostic, Programmable
Reason for Recall
Under certain circumstances the patient Demographics in a report exported into the EMR may not match the demographics shown in the corresponding Synapse CV clinical report.
Details
- Recalling Firm
- Fujifilm Medical Systems U.S.A., Inc.
- Units Affected
- 16 units
- Distribution
- Nationwide Distribution including PR and the states of IL, IN, FL, GA, MD, MI, MO, MS, NC, NY, OR, and PA, PR and the country of Canada.
- Location
- Stamford, CT
Frequently Asked Questions
What product was recalled? ▼
Fujifilm Synapse Cardiovascular I ProSolv CardioVascular Synapse Cardiovascular v4.0.8 Synapse Cardiovascular v4.0.8 SR1 Intended Use: Picture Archiving and Communication System Computer, Diagnostic, Programmable. Recalled by Fujifilm Medical Systems U.S.A., Inc.. Units affected: 16 units.
Why was this product recalled? ▼
Under certain circumstances the patient Demographics in a report exported into the EMR may not match the demographics shown in the corresponding Synapse CV clinical report.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 20, 2015. Severity: Moderate. Recall number: Z-1612-2015.
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