Reported Mar 24, 2021 · Ongoing
Mindray BeneVision Distributed Monitoring System( DMS) 1. p/n 115-051209-00 2. p/n 115-034414-00 and 115-034413-00 when…
Mindray DS USA, Inc. dba Mindray North America
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Mindray DS USA, Inc. dba Mindray North America · 800 Macarthur Blvd · Mahwah, NJ · 07430-2001
Is this the product you have?
- Mindray BeneVision Distributed Monitoring System( DMS) 1. p/n 115-051209-00 2. p/n 115-034414-00 and 115-034413-00 when used
- with the following software versions03.04.00 04.01.00 04.03.00 04.04.00 04.04.01
- Lot codes and dates
- Serial Numbers
1,137 of 1,137 codes
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
- Serial Numbers
- Amount recalled
- 1938 systems
Where it was sold
- Nationwide
Why it was recalled
BeneVision DMS may intermittently freeze and require a manual reboot after which normal operation resumes. If a freeze occur, patients monitored on a telemetry transmitter will no longer communicate data to the BeneVision DMS
This product could cause temporary or reversible health problems — stop using it.
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