ViSi Mobile Chest Sensor — Class II medical device recall Z-1818-2013
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-1818-2013 |
|---|---|
| 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 | 75 units |
| Serial numbers | ACBE20120900183, ACBE20120900189, ACBE20120900205, ACBE20120900206, ACBE20120900211, ACBE20121000217, ACBE20121000218, ACBE20121000222, ACBE20121000224, ACBE20121000225, ACBE20121000226, ACBE20121000227, ACBE20121000231, ACBE20121000232, ACBE20121000236, ACBE20121000237, ACBE20121000240, ACBE20121000245, ACBE20121000246, ACBE20121000250, ACBE20121000252, ACBE20121000259, ACBE20121000260, ACBE20121000261, ACBE20121000262 and 50 more |
| Model numbers | 93-10014 |
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 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-1818-2013. 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.