Z-2634-2017Class II

TI Transport Monitor/Module Battery Pack

Name: Z-2634-2017 TI Transport Monitor/Module Battery Pack
Creator: Mindray DS USA, Inc. dba Mindray North America
Published: 2017-04-28
License: https://open.fda.gov/license/

Datascope Corp. / initiated 2017-04-28 / Terminated

FDA source

Mindray DS USA, Inc. dba Mindray North America began a recall of TI Transport Monitor/Module Battery Pack Product Usage: intended for monitoring, displaying, reviewing, storing, alarming and transferring of multiple... on 2017-04-28. FDA classified it as Class II and gives the reason as "Mindray has received two reports from outside the United States that the battery pack for TI transport monitor/module overheated". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2634-2017
Classification: Class II
Status: Terminated
Initiated: 2017-04-28
Posted: 2017-06-27
Terminated: 2019-03-22
Recalling firm: Datascope Corp.
Product: TI Transport Monitor/Module Battery Pack Product Usage: intended for monitoring, displaying, reviewing, storing, alarming and transferring of multiple physiological parameters.
Product code: MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Reason for recall: Mindray has received two reports from outside the United States that the battery pack for TI transport monitor/module overheated.
FDA root cause: Under Investigation by firm
Action: Mindray notified their customers on April 28, 2017.Customers are provided information regarding this correction. Once the customer has identified the batteries, the customer should contact Mindray Customer Service to arrange for the no charge delivery of replacements. Mindray Customer Service representatives may be reached at (800) 288-2121 (Option 3), Monday through Friday 8:30 amd -5:30 pm, ET.
Quantity in commerce: 2718 batteries
Distribution: US Nationwide Distribution
Product codes and lots: two sales brochures: p/n: 0002-08-30034 and 0002-08-30035 two copies of labels: 047-014270-00, 047-010964-00, 047-018754-00 two copies of operator's manuals: 115-040812-00 and TNC 14-FZ007-F-001

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2634-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2634-2017	Class II	Terminated	Voluntary: Firm initiated	2017-07-05	2017-06-27

Product code MHX

K152902Class IIPassport Series Patient Monitors (including Passport 17m, Passport 12m and T1)Shenzhen Mindray Bio-Medical Electronics Co., Ltd. / cleared 2016-02-18

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)