Z-0742-2013Class II

Mindray DPM5 Monitor, a vital signs monitor used on human patients in healthcare facilities

Name: Z-0742-2013 Mindray DPM5 Monitor, a vital signs monitor used on human patients in healthcare facilities
Creator: Mindray DS USA, Inc. d.b.a. Mindray North America
Published: 2012-09-05
License: https://open.fda.gov/license/

Datascope Corp. / initiated 2012-09-05 / Terminated / root cause: design

FDA source

Mindray DS USA, Inc. d.b.a. Mindray North America began a recall of Mindray DPM5 Monitor, a vital signs monitor used on human patients in healthcare facilities on 2012-09-05. FDA classified it as Class II and gives the reason as "Mindray has identified an issue with the DPM5 monitors where ST and Arrhythmia features may not be available". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0742-2013
Classification: Class II
Status: Terminated
Initiated: 2012-09-05
Posted: 2013-01-27
Terminated: 2013-10-22
Recalling firm: Datascope Corp.
Product: Mindray DPM5 Monitor, a vital signs monitor used on human patients in healthcare facilities.
Product code: MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Reason for recall: Mindray has identified an issue with the DPM5 monitors where ST and Arrhythmia features may not be available.
Root cause tag: design
FDA root cause: Device Design
Action: Mindray DS USA Inc. sent an Urgent Product Corrective Action letter on September 5, 2012 via Fed Ex with delivery confirmation to all users. The letter identifies the affected product, problem and actions to be taken. Customers were instructed to contact their Mindray Service Representative at 1-800-288-2121 Monday through Friday 8:30-5:30 pm, to schedule a software upgrade.
Quantity in commerce: 13 units
Distribution: US Nationwide Distribution including the states of: VA, TN, FL, & TX
Product codes and lots: p/n 9201F-PA000XX DS- 0C000565 02000335 12000603 12000599 12000597 OCOOO569 9A000247 9A000252 17000648 06000490 05000470 05000466 02000373

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0742-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0742-2013	Class II	Terminated	Voluntary: Firm initiated	2013-02-06	2013-01-27

Product code MWI

K053234Class IIPm-9000 Express Patient MonitorShenzhen Mindray Bio-Medical Electronics Co., Ltd. / cleared 2006-05-04

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)