Device recall

Z-3084-2011: Maquet HL Console for Heart Lung Machine HL20 HL 20 4-pumps console base: P/N…

FDA device recall · Class II · Maquet Inc.

Key facts

Recall number (Z-number) Z-3084-2011
Recall event 59577
Product Maquet HL Console for Heart Lung Machine HL20 HL 20 4-pumps console base: P/N 917741 HL 20 5-pumps console base: P/N 917751 Intended for use as an extracorporeal circulation device for perfusion lasting not more than six hours. The HL console is equipped with a rack for accommodating the system's…
Product code DTQ
Recalling firm Maquet Inc.
Recall class Class II
Status Terminated
Termination date Oct 16, 2012
510(k) numbers K943803
FEI number 3008355164

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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