Z-0170-2019Class II

Mindray BeneVision Distributed Monitoring System (DMS), Part No. 115-034413-00

Name: Z-0170-2019 Mindray BeneVision Distributed Monitoring System (DMS), Part No. 115-034413-00
Creator: Mindray DS USA, Inc. dba Mindray North America
Published: 2018-08-30
License: https://open.fda.gov/license/

Datascope Corp. / initiated 2018-08-30 / Terminated / root cause: software

FDA source

Mindray DS USA, Inc. dba Mindray North America began a recall of Mindray BeneVision Distributed Monitoring System (DMS), Part No. 115-034413-00 on 2018-08-30. FDA classified it as Class II and gives the reason as "The firm has identified performance anomalies with the device caused when more than 64 TD60 telemetry transmitters have been connected to a central station. The anomaly causes some ECG waveforms to appear as a flat line...". 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-0170-2019
Classification: Class II
Status: Terminated
Initiated: 2018-08-30
Posted: 2018-10-17
Terminated: 2018-12-20
Recalling firm: Datascope Corp.
Product: Mindray BeneVision Distributed Monitoring System (DMS), Part No. 115-034413-00
Product code: MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Reason for recall: The firm has identified performance anomalies with the device caused when more than 64 TD60 telemetry transmitters have been connected to a central station. The anomaly causes some ECG waveforms to appear as a flat line at the centralized viewing station and will manifest if more than 64 TD60 transmitters have been connected to a given central station server. Each central station supports only 32 transmitters at a time. For the issue to manifest, the BeneVision DMS needs to be configured to use flexible device assignment, have more than 64 TD60 transmitters, and the workflow must allow 64 TD60s to move around between multiple central stations in the same care area.
Root cause tag: software
FDA root cause: Software design
Action: The firm notified affected consignees on August 30, 2018, via Urgent Medical Device Recall letter. The letter advised customers of the software issue when more than 64 telemetry transmitters have been connected to a central station. Customers were advised to use the system normally, but informed that a Mindray Service Representative would be in contact to arrange for a system software update to be performed at the customer site. Mindrays Technical Support team may be reached at (877) 913-9663 (Option 1), Monday through Friday, 8:30am - 5:30pm ET should you have technical questions. Customers were also asked to complete and return an attached Acknowledgement and Receipt Form.
Quantity in commerce: 5
Distribution: Distributed to accounts in CA, CO, FL, MA, NY, PA, PR, TX, and WV.
Product codes and lots: This potential issue affects BeneVision DMS with software version 03.01.00 to 03.03.00

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0170-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0170-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-24	2018-10-17

Product code MHX

K162607Class IIBeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. / cleared 2017-04-20

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)