FDAAugust 29, 2023device
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
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Unintended movement of bed wheels
What to do
FDA enforcement status: Ongoing
Brands named
arjohuntleigh polska sp z o oarjohuntleigharjohuntleigh polska
UPCs
0505609735120505609734548
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAArjo Tenor mobile passive patient lift, Model Numbers KHA1000 US and KHA1010 US2026-03-10
- FDAArjo medical beds, Models Enterprise 5000X, Enterprise 8000X, Enterprise 9000X and Citadel, assembled with IndiGo Drive Assistance module and retrofitted with IndiGo Drive Assistance modules2023-08-29
- FDAArjo Portable Scale Adaptor, Model Number 700.05725; accessory intended to be used in combination with compatible patient lifting equipment2023-02-17
- FDASara Plus Active Floor Lift2022-04-05
- FDAArjo 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...2021-06-10
- FDAMaxi Sky 1000 (Arjo) and V10 (BHM) Bariatric Ceiling Rail - Mounted Lift with measuring function2021-03-04
- FDAArjo Flat Dynamic Positioning System (DPS) - Product Usage: used in conjunction with passive clip slings is designed for resident transfer in a homecare setting, at nursing homes and other assisted living centers. Please note that the DPS can be utilized only if affixed to ceiling lift or passive...2020-10-06
- FDABariatric Bed Frame System The Citadel Plus Bariatric Bed Frame System is intended for the acute and post-acute care environments. It is not intended for use in the home care environment.2020-07-21
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