Home / Recalls / Medical Devices
Sotera Wireless, Inc. recalls ViSi Mobile Monitor, Catalog No. 92-10010 The ViSi Mobile Monitoring System is intended for use by clinicians and med
Recalled August 7, 2013 · FDA recall Z-1817-2013 · Sotera Wireless
Hazard
Sotera Wireless, Inc. is recalling the ViSi Mobile Monitoring System due to the potential for the Chest Sensor to cause a blister wound. · FDA Class II
Units
90 units
Sold at
US distribution including CA and UT.
Description
Sotera Wireless, Inc. is recalling the ViSi Mobile Monitoring System due to the potential for the Chest Sensor to cause a blister wound.
Product
ViSi Mobile Monitor, Catalog No. 92-10010 The ViSi Mobile Monitoring System is intended for use by clinicians and medically qualified personnel for single or multi-parameter vital signs monitoring of adult patients.
Manufacturer(s)
Sotera Wireless, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →