FDAAugust 22, 2019device
Concerto & Basic Shower Trolly, Model Numbers BAB1000-01 (UDI: (01)05055982788083), BAB1000CON6102 [(01)05056097364483], BAB1007-01 [(01)05055982796255], BAB1101-01 [(01)05055982787949], BAB1102-01 [(01)05055982796156], BAB1103-01 [UDI: (01)05055982796163], BAB1107-01 [(01)05055982796187], BAB200...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The firm has become aware that any of the 4 safety catches may exhibit a mechanical failure (break in one of the arms of safety catch), which in certain circumstances may contribute to the side support unintentionally opening and may lead to a potential risk of a patient fall. The patient falling could lead to various types of injuries.
What to do
FDA enforcement status: Terminated
Brands named
arjohuntleigh polska sp z o oarjohuntleigharjohuntleigh polska
UPCs
050559827880830505609736448305055982796255050559827879490505598279615605055982796163050559827961870505598278810605055982788007050559827961940505598278812005055982788021
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 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
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