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 Monitor 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 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.

Quantity: 90 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