Class II — Sotera Wireless, Inc.
| Recalling firm | Sotera Wireless, Inc. |
|---|---|
| Registered facility | SOTERA WIRELESS (the firm's only registered facility) |
| Classification | Class II |
| 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. |
| Product | 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 |
| Distribution | US distribution including CA and UT. |
| Initiated | 2013-05-23 |
| Classified | 2013-07-29 |
| Terminated | 2013-09-09 |
| Recall number | Z-1817-2013 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Sotera Wireless, Inc. (Z-1817-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/65718/
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