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Mindray DS USA, Inc. dba Mindray North America recalls Mindray DS USA Inc., Passport Series Patient Monitor intended for monitoring, displaying, reviewing, alarming, and trans
Recalled August 24, 2016 · FDA recall Z-2549-2016 · Mindray DS USA, Inc.
Hazard
Mindray has identified a potential leakage issue with the CO2 Module's Dryline II Water Trap used with the Passport Series Patient Monitor. · FDA Class II
Units
360 units
Sold at
Nationwide, Canada
Description
Mindray has identified a potential leakage issue with the CO2 Module's Dryline II Water Trap used with the Passport Series Patient Monitor.
Product
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.
Manufacturer(s)
Mindray DS USA, Inc. dba Mindray North America
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →