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Terminated

V Series Monitor Mindray DS USA, Inc. 800 MacArthur Boulevard. Mahwah, NJ 07430 The Indications for Use for the V Series include the monitoring of the following human physiological parameters: ECG waveform derived from 3, 5, 6 and 12 lead measurements Heart Rate Pulse Oximetry (Sp02) ST Segment Analysis Arrhythmia Detection Non Invasive Blood Pressure (NIBP) Invasive Blood Pressure (IBP) Cardiac Output (CO) Respiratory Gasses Respiration Rate Temperature The V Series Monitor has the capability of performing IV Drug and Hemodynamic Calculations and interfacing with network devices

FDA Recall Z-1102-2012 · Posted 2012-02-24

Recalling FirmMindray DS USA, Inc. d.b.a. Mindray North America
Recall StatusTerminated
Product CodeDRT
Date Initiated2011-10-14
Date Terminated2013-06-11
Product Quantity542 units US ; 153 units International

Reason for Recall

A system database corruption may occur that causes the V Series Monitor to reset.

Firm Action

The firm, Mindray, sent an "URGENT PRODUCT CORRECTIVE ACTION" letter dated October 14, 2011 on October 17, 2011 via certified mail, return receipt requested, signature required to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to contact their Mindray Service Representative at 1-800-288-2121, to arrange for software upgrade of the V Series Monitor(s) in their facility. If you have any questions, contact Manager, Regulatory Affairs and Clinical Affairs at 201-995-8407 or email: [email protected].

Root Cause

Process control

Distribution Pattern

Worldwide distribution: USA (nationwide) including states of: AL, CA, CO, IN, MO, NE, PR, and SD; and countries of: Australia, Chile, Columbia, United Kingdom, and Venezula.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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