Company: Mindray DS USA, Inc. dba Mindray North America
Date of Enforcement Report 9/16/2015
Class lI:
PRODUCT
Multi Parameter Patient Monitor (with Arrhythmia Detection and Alarms) Intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG (3-lead or 5-lead selectable), arrhythmia detection, ST Segment analysis, and heart rate.
Recall Number Z-2737-2015
REASON
Mindray has identified an issue where the DPM 7 Monitor may display a black screen.
RECALLING FIRM/MANUFACTURER
Mindray DS USA, Inc. dba Mindray North America, Mahwah, NJ on 7/27/2015. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
13 units
DISTRIBUTION
Distributed to the states of CT, IA, KY, MS, PA, UT and WA..
___________________________________
