FDAJune 23, 2016device

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.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Mindray has identified a potential leakage issue with the CO2 Module's Dryline II Water Trap used with the Passport Series Patient Monitor.

What to do

FDA enforcement status: Terminated

Brands named

mindray ds usa inc dba mindray north americamindraymindray ds

UPCs

11502091900

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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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. — Recall Details · AllClear