Device recall

Z-0523-2007: Ultraview SL Command Module with Masimo Sp02 Option, a multiparameter patient…

FDA device recall · Class II · Spacelabs Healthcare, Incorporated

Key facts

Recall number (Z-number) Z-0523-2007
Recall event 37077
Product Ultraview SL Command Module with Masimo Sp02 Option, a multiparameter patient monitor.
Product code DSI
Recalling firm Spacelabs Healthcare, Incorporated
Recall class Class II
Status Terminated
Termination date Feb 15, 2011
510(k) numbers K050605
FEI number 3010157426

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 10–99 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

Browse all FDA device recalls (products)