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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 Posted 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/
Manufacturer		 Sotera Wireless, Inc.
9444 Waples St
#280
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
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