Boston Scientific, EMBLEM S-ICD Programmer Model 3200 Programmer. — recall Z-1178-2017
U.S. FDA — Device Enforcement · United States · 2017-01-12 · Class II
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Reported risk: 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.
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