Home / Recalls / Mindray DS USA, Inc. d.b.a. Mindray North America / Z-0528-2013

Z-0528-2013 Class II Terminated

Recalled by Mindray DS USA, Inc. d.b.a. Mindray North America — Mahwah, NJ

FDA device recall Z-0528-2013 was initiated by Mindray DS USA, Inc. d.b.a. Mindray North America on September 24, 2012 and is designated Class II. Reason for recall: Mindray has identified an issue with the V Series Monitor where the monitors touch screen may stop responding to touch. The recall status is terminated (terminated August 15, 2013). Affected quantity: 206 units (180 units domestic, 26 units foreign).

Recall Details

Product Type
Devices
Report Date
December 26, 2012
Initiation Date
September 24, 2012
Termination Date
August 15, 2013
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
206 units (180 units domestic, 26 units foreign)

Product Description

Mindray V12 Size: 320 mm X 320 mm X 450 mm N.W.: 3 kg G.W.: 6 kg Qty:1 Manufactured in China Mindray V21 Size: 515 mm X 335 mm X 685 mm N.W.: 8 kg G.W.: 11 kg Qty:1 Manufactured in China One product, V Series monitor, available in two sizes: The V12 has a 12 inch screen, the V21 has a 21 inch screen. The V Series Monitor is a Multi Parameter Patient Monitor (with Arrhythmia Detection and Alarms) capability of performing IV Drug and Hemodynamic Calculations and interfacing with network devices. It also monitors of the following human physiological parameters: 1) ECG waveform derived from 3, 5, 6 and 12 lead measurements, 2) Heart Rate, 3) Pulse Oximetry (Sp O2), 4) ST Segment Analysis, 5) Arrhythmia Detection, 6) Non Invasive Blood Pressure (NIBP), 7) Invasive Blood Pressure (IBP), 8) Cardiac Output (CO), 9) Respiratory Gasses, 10) Respiration Rate, 11) Temperature, It is intended for intra hospital use under the direct supervision of a licensed healthcare practitioner.

Reason for Recall

Mindray has identified an issue with the V Series Monitor where the monitors touch screen may stop responding to touch.

Distribution Pattern

Worldwide Distribution - USA (nationwide) and internationally to Great Britian, Colombia, and Australia.

Code Information

V Series Monitor P/N's 0998-00-1800-101 and 0998-00-1800- 201.

Other recalls by Mindray DS USA, Inc. d.b.a. Mindray North America

  • Z-0798-2013 Class II — Mindray DS USA, Inc., DPM Central Monitoring System with ambulatory Telepack. Pa (November 28, 2012)
  • Z-0977-2013 Class II — BS-200 Chemistry Analyzer Designed for clinical laboratory use. (November 28, 2012)
  • Z-0742-2013 Class II — Mindray DPM5 Monitor, a vital signs monitor used on human patients in healthcar (September 5, 2012)
  • Z-0291-2013 Class I — Mindray A5 Anesthesia Delivery System Manufactured in China for Mindray DS USA (August 13, 2012)
  • Z-0290-2013 Class I — Mindray A3 Anesthesia Delivery System Manufactured in China for Mindray DS USA (August 13, 2012)
  • Z-2279-2012 Class II — V Series Patient Monitors; Mindray DS USA, Inc. Product Usage: The V Series (May 7, 2012)
  • Z-0630-2013 Class II — DPM Central Station Mindray DS USA, Inc. 800 MacArthur Boulevard, Mahwah, NJ 07 (May 12, 2011)
  • Z-0513-2013 Class II — DPM 6/7 Patient Monitor Manufactured in China for : Mindray DS USA, Inc. 800 (August 11, 2010)

FDA data resources