Reported May 20, 2015 · Terminated
FujiMedical Synapse Cardiovascular I ProSolv CardioVascular. A picture Archiving and Communication System Software…
Fujifilm Medical Systems U.S.A., Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Fujifilm Medical Systems U.S.A., Inc. · 419 West Ave · Stamford, CT · 06902-6343
Is this the product you have?
- FujiMedical Synapse Cardiovascular I ProSolv CardioVascular. A picture Archiving and
- Communication System Software versionsSynapse Cardiovascular v4.0.8 Synapse Cardiovascular v4.0.8 SR1
- Lot codes and dates
- Software versionsSynapse Cardiovascular v4.0.8 Synapse Cardiovascular v4.0.8 SR1
- Amount recalled
- 30 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Measurement values in the EMR may not accurately reflect the actual measurement value on the Synapse Cardiovascular clinical report.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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