Device recall

Z-1198-2009: Low-Level Output Cable. The device is used to allow the information displayed on…

FDA device recall · Class II · Datascope Corporation

Key facts

Recall number (Z-number) Z-1198-2009
Recall event 51178
Product Low-Level Output Cable. The device is used to allow the information displayed on the Intra-aortic balloon pump (IABP) to be displayed on a separate patient monitor.
Product code DSP
Recalling firm Datascope Corporation
Recall class Class II
Status Terminated
Termination date Aug 11, 2009
510(k) numbers K063525
FEI number 1000222374

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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