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.
FDA Recall Z-2549-2016 · Posted None
Recalling FirmMindray DS USA, Inc. dba Mindray North America
Recall StatusTerminated
Product CodeMHX
Date Initiated2016-06-23
Date Terminated2017-03-28
Product Quantity360 units
Reason for Recall
Mindray has identified a potential leakage issue with the CO2 Module's Dryline II Water Trap used with the Passport Series Patient Monitor.
Firm Action
Mindray DS USA inc sent a recall letter on 6/23/2016 to their customers.
Root Cause
Under Investigation by firm
Distribution Pattern
Nationwide, Canada
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.