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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 Posted July 29, 2013
Recall Status1 Terminated 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MWI and Original Applicant = SOTERA WIRELESS, INC
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