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Mindray DS USA, Inc. d.b.a. Mindray North America recalls Mindray DS USA, Inc., DPM Central Monitoring System with ambulatory Telepack. Part numbers: 300BF-PA00002, and 300BF-PA0
Recalled February 20, 2013 · FDA recall Z-0798-2013 · Mindray DS USA, Inc.
Hazard
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. · FDA Class II
Units
51 units
Sold at
Nationwide Distribution.
Description
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.
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.
Manufacturer(s)
Mindray DS USA, Inc. d.b.a. Mindray North America
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →