ViSi Mobile Chest Sensor (3 lead-wire ECG, AAMI), Catalog No. 93-10014 The ViSi Mobile Monitoring System is intended for
FDA device recall Z-1818-2013 · posted 2013-07-29 · Terminated
Recall details
- Recalling firm
- Sotera Wireless, Inc.
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- MWI
- Quantity affected
- 75 units
- Distribution
- US distribution including CA and UT.
- Date initiated
- 2013-05-23
- Date posted
- 2013-07-29
- Date terminated
- 2013-09-09
- Location
- San Diego, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VISI MOBILE MONITORING SYSTEM (K122036) | Sotera Wireless, Inc. | 2012-08-15 |
| VISI MOBILE MONITORING SYSTEM (K112478) | Sotera Wireless, Inc. | 2012-03-22 |