Device recall

Z-0477-2013: Enterprise 9000 Bed; an AC-powered adjustable hospital bed with built-in…

FDA device recall · Class II · Arjo, Inc. dba ArjoHuntleigh

Key facts

Recall number (Z-number) Z-0477-2013
Recall event 63187
Product Enterprise 9000 Bed; an AC-powered adjustable hospital bed with built-in electronic weigh scale, patient bed exit alarm, and under bed anti-entrapment system; ArjoHuntleigh AB, Eslov, Sweden; Models 9000, 9600, 9700 and 9800 General medicine, general and specialist surgery, care of the elderly, HDU…
Product code FNL
Recalling firm Arjo, Inc. dba ArjoHuntleigh
Recall class Class II
Status Terminated
Termination date Sep 13, 2016
FEI number 1419652

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)