FDA Device recall Z-0612-2024

Arjo medical beds, Models Enterprise 5000X, Enterprise 8000X, Enterprise 9000X and Citadel, assembled with IndiGo Drive Assistance module a…

FDA Device
Class II
ongoing
Published 2024-01-03

On 2024-01-03 the FDA classified a Class II recall of Arjo medical beds, Models Enterprise 5000X, Enterprise 8000X, Enterprise 9000X and Citadel, assembled with IndiGo Drive Assistance module a… by Arjohuntleigh Polska Sp Z O O, citing unintended movement of bed wheels.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-0612-2024
Classification	Class II
Status	ongoing
Initiated	2023-08-29
Published	2024-01-03
Last updated	2026-09-13 11:56 UTC
Company	Arjohuntleigh Polska Sp Z O O
Distribution	CA, IL, NV, NY, PA, SD, TN

Product

Arjo medical beds, Models Enterprise 5000X, Enterprise 8000X, Enterprise 9000X and Citadel, assembled with IndiGo Drive Assistance module and retrofitted with IndiGo Drive Assistance modules

Reason

Unintended movement of bed wheels

Identifiers

code_info	a) UDI/DI 050560973512, serial numbers: P0595355, P0595356, P0595357, P0595358, P0595359, P0595360, P0595361, P0595362… a) UDI/DI 050560973512, serial numbers: P0595355, P0595356, P0595357, P0595358, P0595359, P0595360, P0595361, P0595362, P0595363, P0595364, P0595365, P0595366, P0595367, P0595368, P0595369, P0595370, P0595371, P0595372, P0595373, P0595374, P0595375, P0595376, P0595377, P0595378, P0595379, P0595380, P0595381, P0595382, P0595383, P0595384, P0595385, P0595386, P0595387, P0595468, P0595469, P0595470, P0595471, P0595472, P0595473, P0595474, P0595475, P0595476, P0595477, P0595478, P0595479, P0595480, P0595481, P0595482, P0595483, P0595484, P0595485, P0595486, P0595487, P0595488, P0595489, P0595490, P0595491, P0595492, P0595493, P0595494, P0595495, P0595496, P0595497, P0595498, P0595499, P0595500, P0595840, P0595841, P0595842, P0595843, P0595844, P0595845, P0595846, P0595847, P0595848, P0595849, P0595850, P0595851, P0595852, P0595853, P0595854, P0595855, P0595856, P0595857, P0595858, P0595859, P0595860, P0595861, P0595862, P0595863, P0595864, P0595865, P0595866, P0595867, P0595868, P0595869,

code_info

a) UDI/DI 050560973512, serial numbers: P0595355, P0595356, P0595357, P0595358, P0595359, P0595360, P0595361, P0595362…

a) UDI/DI 050560973512, serial numbers: P0595355, P0595356, P0595357, P0595358, P0595359, P0595360, P0595361, P0595362, P0595363, P0595364, P0595365, P0595366, P0595367, P0595368, P0595369, P0595370, P0595371, P0595372, P0595373, P0595374, P0595375, P0595376, P0595377, P0595378, P0595379, P0595380, P0595381, P0595382, P0595383, P0595384, P0595385, P0595386, P0595387, P0595468, P0595469, P0595470, P0595471, P0595472, P0595473, P0595474, P0595475, P0595476, P0595477, P0595478, P0595479, P0595480, P0595481, P0595482, P0595483, P0595484, P0595485, P0595486, P0595487, P0595488, P0595489, P0595490, P0595491, P0595492, P0595493, P0595494, P0595495, P0595496, P0595497, P0595498, P0595499, P0595500, P0595840, P0595841, P0595842, P0595843, P0595844, P0595845, P0595846, P0595847, P0595848, P0595849, P0595850, P0595851, P0595852, P0595853, P0595854, P0595855, P0595856, P0595857, P0595858, P0595859, P0595860, P0595861, P0595862, P0595863, P0595864, P0595865, P0595866, P0595867, P0595868, P0595869,

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0612-2024%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.