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 Initiated
- June 23, 2016
- Terminated
- March 28, 2017
- Recall Number
- Z-2549-2016
- Quantity
- 360 units
- Firm Location
- Mahwah, NJ
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.
Distribution
Nationwide, Canada
Lot / Code Info
100-00080-00 - Dyrline II Water Trap, Adult 115-020919-00- CO2 Module with Accessory Kit, Adult and Pediatric Lot #1534, 1537, 1538, 1541, 1545, 1547, 1548, 1602, and 1606
Root Cause
Under Investigation by firm
Action Taken
Mindray DS USA inc sent a recall letter on 6/23/2016 to their customers.
More recalls by Mindray Ds Usa, Inc. D.B.A. Mindray North America
Hardware configuration of the BeneVision Central Monitoring System (CMS), marketed as BeneVision Dis...
Dec 12, 2025
Isoflurane (ISO) V90 Electronic Vaporizer with the A9 Anesthesia System. Labeled as the following:...
Nov 26, 2025
Sevoflurane (SEVO) V90 Electronic Vaporizer with the A9 Anesthesia System. Labeled as the following:...
Nov 26, 2025