Reported Feb 15, 2017 · Terminated
Boston Scientific, EMBLEM S-ICD Programmer Model 3200 Programmer.
Boston Scientific Corporation
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: Boston Scientific Corporation · 4100 Hamline Ave N · Saint Paul, MN · 55112-5700
Is this the product you have?
- Boston Scientific, EMBLEM S-ICD Programmer Model 3200 Programmer.
- Lot codes and dates
- All serial numbers.
- Amount recalled
- 4,500
Where it was sold
Why it was recalled
There is a potential for radio frequency (RF) interference to alter wireless communication from a programmer, which in rare instances may cause an S-ICD to perform an unintended command. This behavior can only occur during an active, in-clinic interrogation/programming session with the Model 3200 S-ICD programmer. There is no risk of this behavior occurring when the LATITUDE Patient Management System communicates with an S-ICD in an ambulatory setting.
This product could cause temporary or reversible health problems — stop using it.
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