Z-0630-2013Class II

DPM Central Station Mindray DS USA, Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 The Central Monitoring...

Name: Z-0630-2013 DPM Central Station Mindray DS USA, Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 The Central Monitoring...
Creator: Mindray DS USA, Inc. d.b.a. Mindray North America
Published: 2011-05-12
License: https://open.fda.gov/license/

Datascope Corp. / initiated 2011-05-12 / Terminated / root cause: software

FDA source

Mindray DS USA, Inc. d.b.a. Mindray North America began a recall of DPM Central Station Mindray DS USA, Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 The Central Monitoring Station (CMS) network transfers information between... on 2011-05-12. FDA classified it as Class II and gives the reason as "There is a software anomaly with the DPM Central Monitoring System where the trend data of one patient maybe replaced with the trend data of a second patient". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0630-2013
Classification: Class II
Status: Terminated
Initiated: 2011-05-12
Posted: 2013-01-03
Terminated: 2013-02-19
Recalling firm: Datascope Corp.
Product: DPM Central Station Mindray DS USA, Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 The Central Monitoring Station (CMS) network transfers information between DOM Central Station and other network devices. It also allows information transfer between several CMS. Network connections consist of hardwired network cables and or WLAN connections. The DPM Central Station is used for remote monitor management, storing, printing, reviewing, or processing of information from net worked devices, and it is operated by medical personnel in hospitals or medical institutions.
Product code: MSX System, Network And Communication, Physiological Monitors
Reason for recall: There is a software anomaly with the DPM Central Monitoring System where the trend data of one patient maybe replaced with the trend data of a second patient.
Root cause tag: software
FDA root cause: Software design
Action: Mindray sent a Product Corrective Action letter dated May 12, 2012, to all affected customers via certified mail return receipt requested to two medical facilities. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed that the issue would be corrected through a softweare upgrade of the affected product. A Mindray Service Representative would contact their facility to arrange for the software upgrade at no cost to them. For questions regarding this recall call 1-800-288-2121.
Quantity in commerce: two units
Distribution: Nationwide Distribution including OH and GA
Product codes and lots: 510 K K080192 P/N 300BF-PA200002

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0630-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0630-2013	Class II	Terminated	Voluntary: Firm initiated	2013-01-09	2013-01-03

Product code MSX

K080192Class IIHypervisor VI Central Monitoring System (Including Tms)Shenzhen Mindray Bio-Medical Electronics Co., Ltd. / cleared 2008-04-03

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)