Z-2737-2015Class II

Mindray DPM 7 Monitor, Multi Parameter Patient Monitor (with Arrhythmia Detection and Alarms) Intended to be...

Name: Z-2737-2015 Mindray DPM 7 Monitor, Multi Parameter Patient Monitor (with Arrhythmia Detection and Alarms) Intended to be...
Creator: Mindray DS USA, Inc. dba Mindray North America
Published: 2015-07-27
License: https://open.fda.gov/license/

Datascope Corp. / initiated 2015-07-27 / Terminated

FDA source

Mindray DS USA, Inc. dba Mindray North America began a recall of Mindray DPM 7 Monitor, Multi Parameter Patient Monitor (with Arrhythmia Detection and Alarms) Intended to be used for monitoring, displaying, reviewing... on 2015-07-27. FDA classified it as Class II and gives the reason as "The DPM 7 Monitors may display a black screen". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2737-2015
Classification: Class II
Status: Terminated
Initiated: 2015-07-27
Posted: 2015-09-04
Terminated: 2017-05-02
Recalling firm: Datascope Corp.
Product: Mindray DPM 7 Monitor, Multi Parameter Patient Monitor (with Arrhythmia Detection and Alarms) Intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG (3-lead or 5-lead selectable), arrhythmia detection, ST Segment analysis, and heart rate.
Product code: MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Reason for recall: The DPM 7 Monitors may display a black screen.
FDA root cause: Under Investigation by firm
Action: Mindray sent an Urgent Medical Device Correction / DPM 7 Monitor letter, dated July 27, 2015, to their affected customers via certified mail and return receipt. The letter identified the problem as well as the affected product, adverse effects on patients, and corrective action. The firm will repair the potentially affected monitor at no cost to the customer. Customers are to contact their Mindray Service Representative at 1-800-288-2121 to arrange for the repair.
Quantity in commerce: 13 units
Distribution: Distributed to the states of CT, IA, KY, MS, PA, UT and WA.
Product codes and lots: Lot #14A18, PN: 6800F-PA00001, Serial Numbers: DU- 46002583, DU-46002587, DU-46002588, DU-46002589, DU-46002592, DU-46002594, DU-46002595, DU-46002596, DU-46002599, DU-46002600, DU-46002601, DU-46002605 and DU-46002606

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2737-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2737-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-16	2015-09-04

Product code MHX

K092449Class IIBeneview T Series Patient Monitors, Models Beneview T8, T6 and T5Shenzhen Mindray Bio-Medical Electronics Co., Ltd. / cleared 2010-08-30

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)