Z-0837-2015Class II

DPM 6 Patient Monitor and DPM 7 Patient Monitor. The product affected is the Mindray IBP module, P/N is...

Name: Z-0837-2015 DPM 6 Patient Monitor and DPM 7 Patient Monitor. The product affected is the Mindray IBP module, P/N is...
Creator: Mindray DS USA, Inc. dba Mindray North America
Published: 2014-10-06
License: https://open.fda.gov/license/

Datascope Corp. / initiated 2014-10-06 / Terminated / root cause: manufacturing process

FDA source

Mindray DS USA, Inc. dba Mindray North America began a recall of DPM 6 Patient Monitor and DPM 7 Patient Monitor. The product affected is the Mindray IBP module, P/N is 6800-30-50485 for use with Mindray DPM 6 and DPM 7... on 2014-10-06. FDA classified it as Class II and gives the reason as "Mindray has identified an issue that involves the IBP module used with the DPM 6 and DPM 7 Monitor where the IBP measurement data may be displayed in an incorrect IBP tile on the monitors display". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0837-2015
Classification: Class II
Status: Terminated
Initiated: 2014-10-06
Posted: 2014-12-19
Terminated: 2017-06-06
Recalling firm: Datascope Corp.
Product: DPM 6 Patient Monitor and DPM 7 Patient Monitor. The product affected is the Mindray IBP module, P/N is 6800-30-50485 for use with Mindray DPM 6 and DPM 7 patient monitors . Intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters.
Product code: MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Reason for recall: Mindray has identified an issue that involves the IBP module used with the DPM 6 and DPM 7 Monitor where the IBP measurement data may be displayed in an incorrect IBP tile on the monitors display.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Mindray DS USA, Inc. sent an Urgent Field Corrective Action Letter dated 10/6/2014 to their customers via certified mail with return receipt. The letter identified the affected product, the problem, adverse effects on the patient, and corrective actions. Customers are asked to either verify that the IBP modules are not affected by following the steps provided in the "Procedures for Verifying IBP Channel Connections;" or to discontinue use of the IBP modules until a Mindray Service Representative contacts them and performs the test to verify the function of the IBP modules. Customers are to contact their local Mindray Service Representative at 1-800-288-2121 to inform them of which corrective action will be taken. Questions should be directed to Diane Arpino at 201-995-8407 or [email protected].
Quantity in commerce: 455 units
Distribution: Distributed to the states of AL, CA, CO, FL, GA, IA, IL, IN, LA. MA, MO, MS, MT, NC, ND, NY, OH, PA, SC, TX, VA, WA and WV.
Product codes and lots: DPM 6 - PN: C-047-000199-00 and DPM 7 - PN: C-047-000200-00, IBP Module P/N: 6800-30-50485

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0837-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0837-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-31	2014-12-19

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)