Device recall

Z-2588-2021: Arjo Citadel beds originally assembled with the IndiGo modules during…

FDA device recall · Class II · ARJOHUNTLEIGH POLSKA Sp. z.o.o.

Key facts

Recall number (Z-number) Z-2588-2021
Recall event 88469
Product Arjo Citadel beds originally assembled with the IndiGo modules during manufcturing, model number CX812A3J3AMAD0; and IndiGo modules (retrofit kits) that can be installed on Citadel (model no. INDIDAA) or Enterprise (model no. INDIJAA) beds manufactured without IndiGo modules assembled at the time of…
Product code FNL
Recalling firm ARJOHUNTLEIGH POLSKA Sp. z.o.o.
Recall class Class II
Status Terminated
Termination date Feb 3, 2026
FEI number 3007420694

At a glance

  • None 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)