ArjoHuntleigh Sara Combilizer; Intended to facilitate early immobilization, rehabilitation, and care of patients.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
ArjoHuntleigh has concluded that a device tipping hazard may occur on the current Sara Combilizer lifting mechanism, providing a potential for risk to the patient or the caregiver. The tipping phenomenon has been found during internal device testing. To date, there have been no adverse events or customer complaints related to the tipping phenomenon. The tipping hazard may occur when fully loaded Sara Combilizer in "stretcher mode" is lifted to the highest position (approximately 984 mm = 38 3/4") and tilted backwards to the angle of 25 degrees¿-28 degrees¿. Although such scenario has been defined as highly unlikely to occur during use with patients, as a commitment to quality, ArjoHuntleigh is providing customers with information on action needed. The Sara Combilizer may stay in use until the upgrade will be performed, on the condition that the tilt angle in the device ''stretcher mode" will be no greater than minus 15 degrees¿ and the device is not loaded over 330 lbs (150 kg).
What to do
FDA enforcement status: Terminated
Brands named
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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