Device recall

Z-2380-2012: Spacelabs Ultraview DM3 Monitor Model Number: 91330-NT The Ultraview DM3 Monitor…

FDA device recall · Class II · Zoe Medical Incorporated

Key facts

Recall number (Z-number) Z-2380-2012
Recall event 62939
Product Spacelabs Ultraview DM3 Monitor Model Number: 91330-NT The Ultraview DM3 Monitor is indicated for use by health care professionals for monitoring patient vital signs. The Ultraview DM3 Monitor is intended for monitoring, recording, and alarming basic vital signs on adult and pediatric patients…
Product code MHX
Recalling firm Zoe Medical Incorporated
Recall class Class II
Status Terminated
Termination date Sep 18, 2012
510(k) numbers K093802
FEI number 3003294644

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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