Device recall

Z-1313-2010: Datascope AS3000 Anesthesia System; Mindray, North America. The AS3000…

FDA device recall · Class II · Mindray DS USA, Inc., dba Datascope Patient Monitoring

Key facts

Recall number (Z-number) Z-1313-2010
Recall event 54851
Product Datascope AS3000 Anesthesia System; Mindray, North America. The AS3000 Anesthesia Delivery System is a continuous flow inhalation gas anesthesia system that delivers anesthetic vapor, provides for automatic and manual modes of ventilation, and is equipped with a monitoring system for ventilation…
Product code BSZ
Recalling firm Mindray DS USA, Inc., dba Datascope Patient Monitoring
Recall class Class II
Status Terminated
Termination date Apr 25, 2012
510(k) numbers K080175
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

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