Device recall

Z-2243-2026: GE HealthCare APEXPRO v5.0 - ARK2250 - Software Disaster Recovery USB Kit…

FDA device recall · Class II · GE Medical Systems Information Technologies Inc

Key facts

Recall number (Z-number) Z-2243-2026
Recall event 98938
Product GE HealthCare APEXPRO v5.0 - ARK2250 - Software Disaster Recovery USB Kit - Orderable by GE Service only, REF #2108523-01; ApexPro CARESCAPE Telemetry Server (CTS) v5.0; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Product code MHX
Recalling firm GE Medical Systems Information Technologies Inc
Recall class Class II
Status Open, Classified
510(k) numbers K103142
FEI number 3001570235

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

Browse all FDA device recalls (products)