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
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