Recall Z-0798-2013— Mindray DS USA, Inc. d.b.a. Mindray North America
Class II · Terminated
Class II FDA medical device recall by Mindray DS USA, Inc. d.b.a. Mindray North America, initiated 2012-11-28, terminated 2013-08-15. It names one FDA 510(k) clearance: K080192. 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.. 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
- Mindray DS USA, Inc. d.b.a. Mindray North America
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-11-28
- Terminated
- 2013-08-15
- Firm location
- Mahwah, NJ, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.