Z-0798-2013Class II

Mindray DS USA, Inc., DPM Central Monitoring System with ambulatory Telepack. Part numbers: 300BF-PA00002...

Name: Z-0798-2013 Mindray DS USA, Inc., DPM Central Monitoring System with ambulatory Telepack. Part numbers: 300BF-PA00002...
Creator: Mindray DS USA, Inc. d.b.a. Mindray North America
Published: 2012-11-28
License: https://open.fda.gov/license/

Datascope Corp. / initiated 2012-11-28 / Terminated / root cause: software

FDA source

Mindray DS USA, Inc. d.b.a. Mindray North America began a recall of Mindray DS USA, Inc., DPM Central Monitoring System with ambulatory Telepack. Part numbers: 300BF-PA00002, and 300BF-PA00003 (DPM Central Monitoring System)... on 2012-11-28. FDA classified it as Class II and gives the reason as "Mindray has identified a software anomaly that may where, in the presence of an asystole, the Telepack ECG waveform may produce a unique step pattern (instead of a flat line) if Lead 1 or V is being utilized for...". 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-0798-2013
Classification: Class II
Status: Terminated
Initiated: 2012-11-28
Posted: 2013-02-11
Terminated: 2013-08-15
Recalling firm: Datascope Corp.
Product: Mindray DS USA, Inc., DPM Central Monitoring System with ambulatory Telepack. Part numbers: 300BF-PA00002, and 300BF-PA00003 (DPM Central Monitoring System) 115-006908-01, -03, -04 (DPM software upgrade kit). The DPM Central Monitoring System transfers information between DPM Central station and other networked devices.
Product code: MSX System, Network And Communication, Physiological Monitors
Reason for recall: Mindray has identified a software anomaly that may where, in the presence of an asystole, the Telepack ECG waveform may produce a unique step pattern (instead of a flat line) if Lead 1 or V is being utilized for detecting cardiac arrhythmia.
Root cause tag: software
FDA root cause: Software design
Action: Mindray North America/ Mindray DS USA Inc. sent an "URGENT PRODUCT CORRECTION ACTION" letter dated November 28, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact your Mindray Service Representative at 1-800-288-2121 for questions relating to this issue.
Quantity in commerce: 51 units
Distribution: Nationwide Distribution.
Product codes and lots: Part No Serial No 300BF-PA00002 EH-17000037 300BF-PA00002 EH-17000032 300BF-PA00002 EH-17000033 300BF-PA00002 EH-25000099 300BF-PA00002 EH-18000043 300BF-PA00003 EH-1A000072 300BF-PA00002 EH-22000088 300BF-PA00003 EH-1A000073 300BF-PA00002 EH-12000060 300BF-PA00002 EH-17000038 300BF-PA00003 EH-21000077 300BF-PA00002 EH-18000058 300BF-PA00002 EH-23000096 300BF-PA00003 EH-19000059 300BF-PA00003 EH-19000060 300BF-PA00002 EH-18000051 300BF-PA00002 EH-12000054 300BF-PA00002 EH-16000029 300BF-PA00002 EH-11000052 300BF-PA00002 EH-17000039 300BF-PA00003 EH-1A000064 300BF-PA00002 EH-18000050 300BF-PA00003 EH-13000078 300BF-PA00003 EH-13000085 300BF-PA00002 EH-18000053 300BF-PA00002 EH-17000036 300BF-PA00002 EH-17000031 300BF-PA00003 EH-17000040 300BF-PA00002 EH-18000054 300BF-PA00002 EH-1A000069 300BF-PA00002 EH-12000062 300BF-PA00002 EH-21000076 115-006908-04 Software Kit 300BF-PA00003 EH-13000083 300BF-PA00003 EH-13000084 300BF-PA00003 EH-22000087 300BF-PA00002 EH-18000056 300BF-PA00002 EH-17000035 300BF-PA00002 EH-18000048 300BF-PA00002 EH-18000052 300BF-PA00003 EH-21000081 300BF-PA00002 EH-17000030 115-006908-03 Software Kit 115-006908-03 Software Kit 115-006908-03 Software Kit 300BF-PA00003 EH-19000062 300BF-PA00002 EH-18000057 300BF-PA00003 EH-22000083 300BF-PA00002 EH-11000051 300BF-PA00002 EH-18000041 300BF-PA00002 EH-21000082.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0798-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0798-2013	Class II	Terminated	Voluntary: Firm initiated	2013-02-20	2013-02-11

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)