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

Recall Z-2549-2016 — Mindray DS USA Inc., Passport Series Patient Monitor intended for monitoring, displaying, reviewing, alarming, and transferring of multiple physiological parameters including ECG (3-lead, 5-lead or 12-lead selectable, arrythmia detection, ST segment analysis, and heart rate (HR), Respiration rate.

U.S. FDA — Device Enforcement · United States · 2016-06-23 · Class II

AI-assisted, human-edited — this page is drafted with AI from public-source data, then reviewed before publication. How we use AI →

Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2549-2016
Date of alert: 2016-06-23
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: Mindray has identified a potential leakage issue with the CO2 Module's Dryline II Water Trap used with the Passport Series Patient Monitor.

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.

Related