Device recall

Z-0170-2019: Mindray BeneVision Distributed Monitoring System (DMS), Part No. 115-034413-00

FDA device recall · Class II · Mindray DS USA, Inc. dba Mindray North America

Key facts

Recall number (Z-number) Z-0170-2019
Recall event 81084
Product Mindray BeneVision Distributed Monitoring System (DMS), Part No. 115-034413-00
Product code MHX
Recalling firm Mindray DS USA, Inc. dba Mindray North America
Recall class Class II
Status Terminated
Termination date Dec 20, 2018
510(k) numbers K162607
FEI number 2221819

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 100–999 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

Browse all FDA device recalls (products)