Device recall

Z-0018-05: Trio Monitor. Cardiac Monitor (including cardiotachometer and rate alarm).

FDA device recall · Class II · Datascope Corp

Key facts

Recall number (Z-number) Z-0018-05
Recall event 30145
Product Trio Monitor. Cardiac Monitor (including cardiotachometer and rate alarm).
Product code NWI
Recalling firm Datascope Corp
Recall class Class II
Status Terminated
Termination date Sep 15, 2005
510(k) numbers K032338
FEI number 2221819

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 1–9 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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