Recall Z-1817-2013 ยท MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Sotera Wireless, Inc.
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.
| Date | Jul 29, 2013 (initiated May 23, 2013) |
| Status | Terminated |
| Reason | Sotera Wireless, Inc. is recalling the ViSi Mobile Monitoring System due to the potential for the Chest Sensor to cause a blister wound. |
| Root 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 | 90 units |
| Distribution | US distribution including CA and UT. |
| FDA record | Open on fda.gov |