Device recall

Z-0631-2010: GE ApexPro Oximeter systems (ApexPro CH or ApexPro FH with ApexPro Telemetry…

FDA device recall · Class II · General Electric Medical Systems Information Technology

Key facts

Recall number (Z-number) Z-0631-2010
Recall event 53980
Product GE ApexPro Oximeter systems (ApexPro CH or ApexPro FH with ApexPro Telemetry version 3.9 software)
Product code DQA
Recalling firm General Electric Medical Systems Information Technology
Recall class Class II
Status Terminated
Termination date May 24, 2012
510(k) numbers K980299
FEI number 2124823

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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