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U.S. Department of Health and Human Services

Class 2 Device Recall ViSi Mobile Chest Sensor (3 leadwire ECG, AAMI),

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  Class 2 Device Recall ViSi Mobile Chest Sensor (3 leadwire ECG, AAMI), see related information
Date Initiated by Firm May 23, 2013
Date Posting Updated July 29, 2013
Recall Status1 Terminated 3 on September 09, 2013
Recall Number Z-1818-2013
Recall Event ID 65718
510(K)Number K112478  K122036  
Product Classification Monitor,physiological,patient(without arrhythmia detection or alarms) - Product Code MWI
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.
Code Information Serial No., ACBE20120900183, ACBE20120900189, ACBE20120900205, ACBE20120900206, ACBE20121000217, ACBE20121000224, ACBE20121000225, ACBE20121000226, ACBE20121000231, ACBE20121000232, ACBE20121000236, ACBE20121000240, ACBE20121000245, ACBE20121000250, ACBE20121000252, ACBE20121000259, ACBE20121000260, ACBE20121000261, ACBE20121000262, ACBE20121000271, ACBE20121100292, ACBE20121100296, ACBE20121100300, ACBE20130200445, ACBE20120900211, ACBE20121000222, ACBE20121000237, ACBE20121000246, ACBE20121000263, ACBE20121100277, ACBE20121100280, ACBE20121100283, ACBE20121100287, ACBE20121100291, ACBE20121100356, ACBE20121100360, ACBE20121100364, ACBE20130100394, ACBE20130100395, ACBE20130100397, ACBE20130100398, ACBE20130100399, ACBE20130100401, ACBE20130100402, ACBE20130100404, ACBE20130100405, ACBE20130100410, ACBE20130100411, ACBE20130100412, ACBE20130100415, ACBE20130100417, ACBE20121000218, ACBE20121000227, ACBE20121000270, ACBE20121100282, ACBE20121100286, ACBE20121100288, ACBE20121100301, ACBE20121100350, ACBE20121100352, ACBE20121100355, ACBE20130100369, ACBE20130100370, ACBE20130100374, ACBE20130100375, ACBE20130100376, ACBE20130100378, ACBE20130100379, ACBE20130100380, ACBE20130100384, ACBE20130100385, ACBE20130100388, ACBE20130100390, ACBE20130100392, ACBE20130100393.
Recalling Firm/
Sotera Wireless, Inc.
9444 Waples St
San Diego CA 92121-2939
Manufacturer Reason
for Recall
Sotera Wireless, Inc. is recalling the ViSi Mobile Monitoring System due to the potential for the Chest Sensor to cause a blister wound.
FDA Determined
Cause 2
Device Design
Action Sotera sent an Urgent Product Recall letter dated May 23. 2013, to all affected customers. The letter informed the customers of the problems identified and the actions to be taken. Customers were instructed to report any adverse reactions experienced with the use of this product and or quality problems to the FDA's MedWatch Program by: www.fda.gov/medwatch, (800) FDA-1008, fax (800) FDA-0178. Customers were also instructed to contact Sotera Wireless Technical Support at (866) 794-5526 for questions.
Quantity in Commerce 75 units
Distribution US distribution including CA and UT.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MWI and Original Applicant = SOTERA WIRELESS, INC