ViSi Mobile Monitor — Class II medical device recall Z-1817-2013

Terminated recall by Sotera Wireless, Inc., reported 2013-08-07, distributed in CA, UT. Sotera Wireless, Inc. is recalling the ViSi Mobile Monitoring System due to the potential for the Chest Sensor

Recall number	`Z-1817-2013`
Product type	Medical device
Classification	Class II
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	Sotera Wireless, Inc., San Diego, CA, United States
Recall initiated	2013-05-23
Classified	2013-07-29
Reported by FDA	2013-08-07
Terminated	2013-09-09
Distributed	CA, UT
Quantity	90 units
Serial numbers	`AAAA20120800501`, `AAAA20120800519`, `AAAA20120800520`, `AAAA20120800526`, `AAAA20120800527`, `AAAA20120800533`, `AAAA20120800537`, `AAAA20120800538`, `AAAA20120800539`, `AAAA20120900544`, `AAAA20120900548`, `AAAA20120900557`, `AAAA20120900562`, `AAAA20120900564`, `AAAA20120900577`, `AAAA20120900578`, `AAAA20120900580`, `AAAA20120900584`, `AAAA20120900587`, `AAAA20120900591`, `AAAA20121200604`, `AAAA20121200605`, `AAAA20121200606`, `AAAA20121200609`, `AAAA20121200610` and 65 more
Model numbers	`92-10010`

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.

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1817-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.