Mindray BeneVision Distributed Monitoring System (DMS), Part No. 115-034413-00
Class I - DangerousWhat Should You Do?
- Check if you have this product: This potential issue affects BeneVision DMS with software version 03.01.00 to 03.03.00
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Mindray DS USA, Inc. dba Mindray North America
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Mindray BeneVision Distributed Monitoring System (DMS), Part No. 115-034413-00
Product Codes/Lot Numbers:
This potential issue affects BeneVision DMS with software version 03.01.00 to 03.03.00
Distribution:
Distributed in: CA, CO, FL, MA, NY, PA, PR, TX, WV
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0170-2019
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