FDA-Device2013-08-07Class II
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.
Sotera Wireless, Inc.
Hazard
Sotera Wireless, Inc. is recalling the ViSi Mobile Monitoring System due to the potential for the Chest Sensor to cause a blister wound.
Sold states
US distribution including CA and UT.
Affected count
75 units
Manufactured in
9444 Waples St, #280, San Diego, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1818-2013Don't want to check this manually?
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