Class II — Mindray DS USA, Inc. dba Mindray North America
| Recalling firm | Mindray DS USA, Inc. |
|---|---|
| Registered facility | MINDRAY DS USA, Inc. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| 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. |
| Quantity | 113 units (57 United States; 56 International) |
| Distribution | Worldwide Distribution - US including the states of Louisiana, New Jersey, Montana, South Carolina and Wyoming. |
| Initiated | 2014-05-19 |
| Classified | 2014-07-16 |
| Terminated | 2017-04-20 |
| Recall number | Z-2059-2014 |
| 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 — Mindray DS USA, Inc. dba Mindray North America (Z-2059-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/68582/
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