Device recall

Z-0939-2013: Draeger Infinity Acute Care System (IACS) Monitoring Solution. Catalog Number…

FDA device recall · Class II · Draeger Medical, Inc.

Key facts

Recall number (Z-number) Z-0939-2013
Recall event 64447
Product Draeger Infinity Acute Care System (IACS) Monitoring Solution. Catalog Number MS20783 (Infinity MCable-Dual Hemo) Physiological patient monitoring system.
Product code MHX
Recalling firm Draeger Medical, Inc.
Recall class Class II
Status Terminated
Termination date May 20, 2013
510(k) numbers K093788, K113798
FEI number 2517967

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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