Vital Sync RMS 1 — Class II medical device recall Z-2235-2014
Terminated recall by Nellcor Puritan Bennett Inc. (dba Covidien LP), reported 2014-08-20, distributed in CA, CO, GA, IL, IN, LA, MS, TX. Covidien is conducting a field correction of the Vital Sync Virtual Patient Monitoring Platform and Informatic
| Recall number | Z-2235-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Nellcor Puritan Bennett Inc. (dba Covidien LP), Boulder, CO, United States |
| Recall initiated | 2014-07-17 |
| Classified | 2014-08-14 |
| Reported by FDA | 2014-08-20 |
| Terminated | 2014-10-21 |
| Distributed | CA, CO, GA, IL, IN, LA, MS, TX |
| Quantity | 9 |
| Lot numbers | PO643063 |
| Model numbers | 10116080 |
Product
Vital Sync RMS 1.0 when loaded with v2.4 software, packaged on a CD or other electronically controlled device. CDs are packaged in clam shell jeweled cases within a carton box. The Vital Sync Virtual Patient Monitoring Platform is intended to be used by healthcare professionals for the following purposes: 1) To remotely consult regarding a patients status; and 2) To remotely review near real-time patient data, waveforms and alarms in order to utilize this information to aid in clinical decisions and deliver patient care in a timely manner.
Reason for recall
Covidien is conducting a field correction of the Vital Sync Virtual Patient Monitoring Platform and Informatics Manager due to a mismatch between the alarm priority on the medical devices and the Vital Sync system.
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-2235-2014. 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.