Device recall

Z-1389-2022: GE Healthcare Aisys CS2 Anesthesia System, Part number 1011-9050-000; and Avance…

FDA device recall · Class I · GE Healthcare, LLC

Key facts

Recall number (Z-number) Z-1389-2022
Recall event 90424
Product GE Healthcare Aisys CS2 Anesthesia System, Part number 1011-9050-000; and Avance CS2 and Avance CS2 Pro Anesthesia System, Part number 1009-9050-000.
Product code BSZ
Recalling firm GE Healthcare, LLC
Recall class Class I
Status Terminated
Termination date Oct 21, 2024
510(k) numbers K172045
FEI number 2126677

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)