Z-2549-2016Class II

Mindray DS USA Inc., Passport Series Patient Monitor intended for monitoring, displaying, reviewing...

Name: Z-2549-2016 Mindray DS USA Inc., Passport Series Patient Monitor intended for monitoring, displaying, reviewing...
Creator: Mindray DS USA, Inc. dba Mindray North America
Published: 2016-06-23
License: https://open.fda.gov/license/

Datascope Corp. / initiated 2016-06-23 / Terminated

FDA source

Mindray DS USA, Inc. dba Mindray North America began a recall of Mindray DS USA Inc., Passport Series Patient Monitor intended for monitoring, displaying, reviewing, alarming, and transferring of multiple physiological... on 2016-06-23. FDA classified it as Class II and gives the reason as "Mindray has identified a potential leakage issue with the CO2 Module's Dryline II Water Trap used with the Passport Series Patient Monitor". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2549-2016
Classification: Class II
Status: Terminated
Initiated: 2016-06-23
Posted: 2016-08-16
Terminated: 2017-03-28
Recalling firm: Datascope Corp.
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.
Product code: MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
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.
FDA root cause: Under Investigation by firm
Action: Mindray DS USA inc sent a recall letter on 6/23/2016 to their customers.
Quantity in commerce: 360 units
Distribution: Nationwide, Canada
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2549-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2549-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-24	2016-08-16

Product code MHX

K143195Class IIPassport Series Patient Monitors (including Passport 17M, Passport 12M and T1)Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. / cleared 2014-12-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)