Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

ViSi Mobile Chest Sensor (3 lead-wire ECG Recalled by Sotera Wireless, Inc. Due to Sotera Wireless, Inc. is recalling the ViSi Mobile...

Date: May 23, 2013
Company: Sotera Wireless, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Sotera Wireless, Inc. directly.

Affected Products

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.

Quantity: 75 units

Why Was This Recalled?

Sotera Wireless, Inc. is recalling the ViSi Mobile Monitoring System due to the potential for the Chest Sensor to cause a blister wound.

Where Was This Sold?

This product was distributed to 2 states: CA, UT

Affected (2 states)Not affected

About Sotera Wireless, Inc.

Sotera Wireless, Inc. has 2 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report