Recall Z-1818-2013— Sotera Wireless, Inc.

Name: FDA recall Z-1818-2013
Creator: U.S. Food and Drug Administration
Published: 2013-05-23

Class II · Terminated

Class II FDA medical device recall by Sotera Wireless, Inc., initiated 2013-05-23, terminated 2013-09-09. It names 2 FDA 510(k) clearances: K122036, K112478. 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.. Reason: Sotera Wireless, Inc. is recalling the ViSi Mobile Monitoring System due to the potential for the Chest Sensor to cause a blister wound..

Recalling firm: Sotera Wireless, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-05-23
Terminated: 2013-09-09
Firm location: San Diego, CA, United States

510(k) clearances named in this recall

2 on FDA's record

K122036 — VISI MOBILE MONITORING SYSTEMSotera Wireless, Inc.·cleared 2012-08-15
K112478 — VISI MOBILE MONITORING SYSTEMSotera Wireless, Inc.·cleared 2012-03-22

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.