Reported Mar 6, 2019 · Terminated
Sensis Vibe System, Model Number 11007642, with software version VD10B.
Siemens Medical Solutions USA, 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: Siemens Medical Solutions USA, Inc · 40 Liberty Blvd · Malvern, PA · 19355-1418
Is this the product you have?
Sensis Vibe SystemModel Number 11007642with software version VD10B
- Lot codes and dates
- Serial Number 120019
- Amount recalled
- 1
Where it was sold
Why it was recalled
A software error may result in a system crash. The system must be restarted before the clinical procedure can be continued. The ablation treatment must be performed with a different system or without the use of the interface.
This product could cause temporary or reversible health problems — stop using it.
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