Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0798-2013 — 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 oth

U.S. FDA — Device Enforcement · United States · 2012-11-28 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0798-2013
Date of alert: 2012-11-28
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Mindray DS USA, Inc. d.b.a. Mindray North America
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 17000037

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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