V-Series Patient Monitoring System — Class II medical device recall Z-2059-2014
Terminated recall by Mindray DS USA, Inc. dba Mindray North America, reported 2014-07-23, distributed in LA, MT, NJ, SC, WY. ECG interpretation feature issues. False measurements reported when the algorithm cannot determine P wave or Q
| Recall number | Z-2059-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mindray DS USA, Inc. dba Mindray North America, Mahwah, NJ, United States |
| Recall initiated | 2014-05-19 |
| Classified | 2014-07-16 |
| Reported by FDA | 2014-07-23 |
| Terminated | 2017-04-20 |
| Distributed | LA, MT, NJ, SC, WY |
| Reason classes | software |
| Model numbers | 0998-00-1800-101, 0998-00-1800-201 |
Product
V-Series Patient Monitoring System, Manufactured for Mindray DS USA, Inc. Used for monitoring of human physiological parameters. The V-Series Monitor also has the capability of performing IV Drug and Hemodynamic Calculations and interfacing with network devices.
Reason for recall
ECG interpretation feature issues. False measurements reported when the algorithm cannot determine P wave or QRS axis. The Median Complex Report displays the representative beat 25% larger than actual signal input. When a patient date of birth is imported from an external source, the ECG interpretation algorithm uses the default age of 50, and interpretive statements may be incorrect.
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-2059-2014. 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.