Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Mindray DS USA Recalled by Mindray DS USA, Inc. d.b.a. Mindray North America Due to Mindray has identified a software anomaly that may...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Mindray DS USA, Inc. d.b.a. Mindray North America directly.
Affected Products
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.
Quantity: 51 units
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Mindray DS USA, Inc. d.b.a. Mindray North America
Mindray DS USA, Inc. d.b.a. Mindray North America has 9 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report