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Terminated

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.

FDA Recall Z-1818-2013 · Posted 2013-07-29

Recalling FirmSotera Wireless, Inc.
Recall StatusTerminated
Product CodeMWI
Date Initiated2013-05-23
Date Terminated2013-09-09
Product Quantity75 units

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.

Firm 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.

Root Cause

Device Design

Distribution Pattern

US distribution including CA and UT.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K122036VISI MOBILE MONITORING SYSTEMSotera Wireless, Inc. · 2012-08-15K112478VISI MOBILE MONITORING SYSTEMSotera Wireless, Inc. · 2012-03-22

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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