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

Recall Z-1611-2014 — DPM 6 Monitor in use with a Multi Parameter Module (MPM). Patient monitor used for monitoring, displaying, reviewing, storing, and alarming of multiple physiological parameters including ECG, arrhythmia detection, ST segment analysis, heart rate (HR), respiration rate (RESP), temperature, pulse oxy

U.S. FDA — Device Enforcement · United States · 2014-03-05 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1611-2014
Date of alert: 2014-03-05
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Mindray DS USA, Inc. dba Mindray North America
Product category: device
Product type: Devices

Reported risk: The MPM included a cardiac ST/Arrhythmia analysis feature which is not cleared for marketing.

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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