Company:Mindray DS USA, Inc. d.b.a. Mindray North America
Date of Enforcement Report 2/20/2013
Class ll:
PRODUCT
Mindray DS USA, Inc., DPM Central Monitoring System with ambulatory Telepack. Part numbers: 300BF-PA00002, and 300BF-PA00003 (DPM Central Monitoring System) 115-006908-01, -03, -04 (DPM software upgrade kit). The DPM Central Monitoring System transfers information between DPM Central station and other networked devices. Recall Number Z-0798-2013
REASON
Mindray has identified a software anomaly that may where, in the presence of an asystole, the Telepack ECG waveform may produce a unique step pattern (instead of a flat line) if Lead 1 or V is being utilized for detecting cardiac arrhythmia.
RECALLING FIRM/MANUFACTURER
Mindray DS USA, Inc. d.b.a. Mindray North America, Mahwah, NY on 11/28/2012. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
51 units
DISTRIBUTION
Nationwide
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