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Sotera Wireless, Inc. recalls ViSi Mobile Chest Sensor (3 lead-wire ECG, AAMI), Catalog No. 93-10014 The ViSi Mobile Monitoring System is intended
Recalled August 7, 2013 · FDA recall Z-1818-2013 · 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
75 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 Chest Sensor (3 lead-wire ECG, AAMI), Catalog No. 93-10014 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 →