FDA Device recall Z-2059-2014

V-Series Patient Monitoring System, Manufactured for Mindray DS USA, Inc

• FDA Device
• Class II
• terminated
• Published 2014-07-23

On 2014-07-23 the FDA classified a Class II recall of V-Series Patient Monitoring System, Manufactured for Mindray DS USA, Inc by Mindray Ds Usa, citing 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 2….

Read the official FDA Device notice

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

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.

Identifiers

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2059-2014%22

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