FDA-Device2016-08-24Class II
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.
Mindray DS USA, Inc. dba Mindray North America
Hazard
Mindray has identified a potential leakage issue with the CO2 Module's Dryline II Water Trap used with the Passport Series Patient Monitor.
Sold states
Nationwide, Canada
Affected count
360 units
Manufactured in
800 Macarthur Blvd, N/A, Mahwah, NJ, United States
Products
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 notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2549-2016Don't want to check this manually?
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