Company: Boston Scientific Corporation
Date of Enforcement Report 2/152017
Class lI:

PRODUCT

Merge Eye Station. f/k/a: DFC-1024 & DFC-512 Digital Imaging System, WinStation, and WinStation Retinal Imager distributed by Ophthalmic Imaging Systems (OIS). Model number 136 T1700 Capture Stations & 46 T5810 Capture Station
Recall Number Z-1178-2017

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/MANUFACTURER
Boston Scientific Corporation, Saint Paul, MN 55112-5700 on 1/12/2017. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
4500

DISTRIBUTION
Nationwide and Internationally

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