Class 2 Device Recall ViSi Mobile Monitor

• Date Initiated by Firm: May 23, 2013
• Date Posted: July 29, 2013
• Recall Status: Terminated on September 09, 2013
• Recall Number: Z-1817-2013
• 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 Monitor, Catalog No. 92-10010 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. AAAA20120800519 AAAA20120800520 AAAA20120800526 AAAA20120800527 AAAA20120800533 AAAA20120800537 AAAA20120800538 AAAA20120800539 AAAA20120900544 AAAA20120900548 AAAA20120900557 AAAA20120900562 AAAA20120900564 AAAA20120900577 AAAA20120900578 AAAA20120900580 AAAA20120900584 AAAA20120900587 AAAA20120900591 AAAA20130400890 AAAA20130400896 AAAA20130400902 AAAA20130400909 AAAA20120800501 AAAA20121200604 AAAA20121200606 AAAA20121200609 AAAA20121200610 AAAA20121200611 AAAA20121200615 AAAA20121200617 AAAA20121200618 AAAA20121200620 AAAA20121200621 AAAA20121200624 AAAA20121200626 AAAA20121200628 AAAA20121200629 AAAA20121200630 AAAA20121200632 AAAA20121200636 AAAA20121200639 AAAA20121200640 AAAA20121200645 AAAA20121200647 AAAA20130100680 AAAA20130100684 AAAA20130100688 AAAA20130100689 AAAA20130100691 AAAA20130100692 AAAA20130100693 AAAA20130100694 AAAA20130100698 AAAA20130100699 AAAA20130100700 AAAA20130100701 AAAA20130100703 AAAA20121200605 AAAA20121200612 AAAA20121200613 AAAA20121200622 AAAA20121200625 AAAA20121200627 AAAA20121200633 AAAA20121200642 AAAA20121200643 AAAA20121200646 AAAA20121200648 AAAA20121200649 AAAA20121200650 AAAA20121200651 AAAA20121200652 AAAA20121200653 AAAA20130100654 AAAA20130100655 AAAA20130100656 AAAA20130100657 AAAA20130100658 AAAA20130100660 AAAA20130100661 AAAA20130100662 AAAA20130100664 AAAA20130100665 AAAA20130100666 AAAA20130100669 AAAA20130100670 AAAA20130100671 AAAA20130100672 AAAA20130100678
• 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: 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: 90 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