FujiMedical Synapse Cardiovascular I ProSolv recall
FujiMedical Synapse Cardiovascular I ProSolv CardioVascular. A picture Archiving and Communication System Software versions: Synapse Cardiovascular…
Why was FujiMedical Synapse Cardiovascular I ProSolv recalled?
Measurement values in the EMR may not accurately reflect the actual measurement value on the Synapse Cardiovascular clinical report.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Software versions: Synapse Cardiovascular v4.0.8 Synapse Cardiovascular v4.0.8 SR1
- Product
- FujiMedical Synapse Cardiovascular I ProSolv CardioVascular. A picture Archiving and Communication System Software versions: Synapse Cardiovascular…
- Recalling firm
- Fujifilm Medical Systems U.S.A., Inc.
- Quantity
- 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
- Recall date
- May 20, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)