Recall Z-0170-2019— Mindray DS USA, Inc. dba Mindray North America

Name: FDA recall Z-0170-2019
Creator: U.S. Food and Drug Administration
Published: 2018-08-30

Class II · Terminated

Class II FDA medical device recall by Mindray DS USA, Inc. dba Mindray North America, initiated 2018-08-30, terminated 2018-12-20. It names one FDA 510(k) clearance: K162607. Product: Mindray BeneVision Distributed Monitoring System (DMS), Part No. 115-034413-00. Reason: 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..

Recalling firm: Mindray DS USA, Inc. dba Mindray North America
Classification: Class II
Status: Terminated
Initiated: 2018-08-30
Terminated: 2018-12-20
Firm location: Mahwah, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K162607 — BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.·cleared 2017-04-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.