Reported Jun 9, 2021 · Terminated
Synapse Cardiovascular (Synapse CV). Software Versions: 6.0 to 6.2.1 The Synapse Cardiovascular image is a management…
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. · 81 Hartwell Ave Ste 300 · Lexington, MA · 02421-3160
Is this the product you have?
- Synapse Cardiovascular (Synapse CV)
- Software Versions6.0 to 6.2.1 The Synapse Cardiovascular image is a management and reporting system
- Lot codes and dates
- Software Versions6.0 to 6.2.1
- Amount recalled
- 44 US and 4 OUS
Where it was sold
- Nationwide
Why it was recalled
Software versions 6.0.4 to 6.2.1 using Advanced Reporting -possibility that a previously assigned internal patient database ID can be reused for a new patient. It was discovered that this value does not increase when a patient merge activity is executed in a specific sequence
This product could cause temporary or reversible health problems — stop using it.
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