Recall Z-1178-2017— Boston Scientific Corporation
Class II · Terminated
Class II FDA medical device recall by Boston Scientific Corporation, initiated 2017-01-12, terminated 2018-08-09. FDA's recall record names no specific 510(k) clearance for this event. Product: Boston Scientific, EMBLEM S-ICD Programmer Model 3200 Programmer.. Reason: 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..
- Recalling firm
- Boston Scientific Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-01-12
- Terminated
- 2018-08-09
- Firm location
- Saint Paul, MN, United States
Product description
Boston Scientific, EMBLEM S-ICD Programmer Model 3200 Programmer.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.