Recall Z-0170-2019 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Mindray DS USA, Inc. dba Mindray North America
Mindray BeneVision Distributed Monitoring System (DMS), Part No. 115-034413-00
| Date | Aug 30, 2018 |
| Status | Terminated |
| 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 TD60 |
| 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. Customer |
| Quantity | 5 |
| Distribution | Distributed to accounts in CA, CO, FL, MA, NY, PA, PR, TX, and WV. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K162607 | BeneVision Central Monitoring System Shenzhen Mindray Bio-Medical Electronics Co., Ltd., Apr 20, 2017 |