BEUDAMED
    19 results · 52ms · Sources: EU EUDAMED, US FDA

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    Maxi Move Patient Lift with Scale; Manufactured by Arjo Hospital Equipment AB, Eslov, Sweden; Model KMBB4OSU2FUS

    FDA Recall
    Terminated ·Arjo, Inc.·Product code FSG·January 5, 2007

    Maxi Move Patient Lift with Scale; Manufactured by Arjo Hospital Equipment AB, Eslov, Sweden; Model KMBB4MSU2FUS

    FDA Recall
    Terminated ·Arjo, Inc.·Product code FSG·January 5, 2007

    Maxi Move Patient Lift with Scale; Manufactured by Arjo Hospital Equipment AB, Eslov, Sweden; Model KMBB4OLU2FUS

    FDA Recall
    Terminated ·Arjo, Inc.·Product code FSG·January 5, 2007

    Maxi Move Patient Lift with Scale; Manufactured by Arjo Hospital Equipment AB, Eslov, Sweden; Model KMBB4ELU2FUS

    FDA Recall
    Terminated ·Arjo, Inc.·Product code FSG·January 5, 2007

    ARJO,Carendo Multi-Purpose Hygiene Chair; Model BIB2003-01, a non-AC powered patient lift; Manufactured by Arjo Hospital Equipment AB, Eslov, Sweden

    FDA Recall
    Terminated ·Arjo, Inc.·Product code FSA·October 15, 2007

    Maxi Move Scoop Stretcher; Note: The stretcher is an accessory to the Maxi Move Patient Lift; Made by Arjo Hospital Equipment AB, Eslov, Sweden; product number KRA2210-20.

    FDA Recall
    Terminated ·ArjoHuntleigh·Product code FSA·August 18, 2009

    ARJO Carendo Multi-Purpose Hygiene Chair; Model BIB2003-01, a non-AC powered patient lift; Manufactured by Arjo Hospital Equipment AB, Eslov, Sweden. The equipment is intended for hygiene care, showering, and toileting of hospital or nursing home residents under the supervision of trained nursing staff and in accordance with the instructions outlined in the Operating and Product Care Instructions.

    FDA Recall
    Terminated ·ArjoHuntleigh·Product code FSA·June 11, 2009

    ArjoHuntleigh Contoura C1000 series beds are designed to accommodate patients weighing up to 990 lbs. (450 kg). Model C1000 is the basic bed. Model C1080 includes a weighing system and a power outlet for an ArjoHuntleigh approved mattress pump. Product Usage: The Contoura series bariatric beds are electrically operating medical beds with a maximum patient weight of 450 kg. This range is intended for use in hospitals to facilitate management of obese patients. An optional integrated weighing system helps with assessment and management of the patient if required.

    FDA Recall
    Terminated ·Arjo Hospital Equipment AB Verkstadsvagen·Product code FNL·March 17, 2014

    Rotoprone Therapy System. The Rotoprone Therapy System is an advanced patient care system for the treatment and prevention of pulmonary complications.

    FDA Enforcement
    Class II ·Terminated·Arjo Hospital Equipment AB·March 11, 2015

    TriaDyne Proventa Critical Care Therapy System. The TriaDyne Proventa Critical Care Therapy System provides a comprehensive system of pulmonary and skin care therapies for the critically ill, immobilized patient.

    FDA Enforcement
    Class II ·Terminated·Arjo Hospital Equipment AB·March 11, 2015

    ArjoHuntleigh Contoura C1000 series beds are designed to accommodate patients weighing up to 990 lbs. (450 kg). Model C1000 is the basic bed. Model C1080 includes a weighing system and a power outlet for an ArjoHuntleigh approved mattress pump. Product Usage: The Contoura series bariatric beds are electrically operating medical beds with a maximum patient weight of 450 kg. This range is intended for use in hospitals to facilitate management of obese patients. An optional integrated weighing system helps with assessment and management of the patient if required.

    FDA Enforcement
    Class II ·Terminated·Arjo Hospital Equipment AB·October 15, 2014

    Pressure IQ Evolve Mattress; Non-powered mattress replacement system. Intended for patients with medium to high risk for developing pressure ulcers while on a mattress.

    FDA Enforcement
    Class II ·Terminated·Arjo Hospital Equipment AB·March 18, 2015

    RotoRest Delta Advanced Therapy System. The RotoRest Delta Advanced Kinetic Therapy System offers kinetic therapy for the most aggressive treatment of pulmonary complications.

    FDA Enforcement
    Class II ·Terminated·Arjo Hospital Equipment AB·March 11, 2015

    Maxi Move Patient Lift with Lock & Load System (Combi Hanger); Manufactured by Arjo Hospital Equipment AB, Eslov, Sweden; Models KMBB4CLU2FUS, KMBB4MLU2FUS, KMBB4MSU2FUS, KMBB4NLX2FUS, KMBB4NSX2FUS, KMBB4OLU2FUS, KMBB4OSU2FUS, KMBB4PLX2FUS, KMBB4PSX2FUS, KMBB4QLU2FUS, and KMBB4RLX2FUS. The lifter is intended to be used under the direct supervision of trained personnel for the transfer of residents from one location to another.

    FDA Recall
    Terminated ·Arjo, Inc.·Product code FSA·September 8, 2008

    Entroy Pool Lift; a patient lift used in conjunction with a chair or stretcher to lift them in/out of a swimming/therapy pool; Arjo Hospital Equipment AB, Eslov, Sweden; Models GAB1000-01-xx, GAB1000-11-xx and GAC100x Entroy is a pool lift that docks to either a chair or a stretcher and aids disabled people getting in and out of a pool. This equipment is intended for disabled persons who need to transfer in and out of a therapy and swimming pool under supervision of skilled and trained personnel in accordance with the Entroy Operating and Product Care Instructions. All other use must be avoided. Active/semi-active persons can and should use the Entroy chair (with or without chassis) while bedridden persons without trunk stability can and should be transferred with the Entroy stretcher with chassis.

    FDA Recall
    Terminated ·Arjo, Inc. dba ArjoHuntleigh·Product code FSA·August 4, 2011

    RotoRest Delta Advanced Therapy System. The RotoRest Delta Advanced Kinetic Therapy System offers kinetic therapy for the most aggressive treatment of pulmonary complications.

    FDA Recall
    Terminated ·Arjo Hospital Equipment AB HANS MICHELSENSGATAN·Product code IKZ·December 3, 2014

    Pressure IQ Evolve Mattress; Non-powered mattress replacement system. Intended for patients with medium to high risk for developing pressure ulcers while on a mattress.

    FDA Recall
    Terminated ·Arjo Hospital Equipment AB HANS MICHELSENSGATAN·Product code IKY·September 1, 2014

    Rotoprone Therapy System. The Rotoprone Therapy System is an advanced patient care system for the treatment and prevention of pulmonary complications.

    FDA Recall
    Terminated ·Arjo Hospital Equipment AB HANS MICHELSENSGATAN·Product code IKZ·December 3, 2014

    TriaDyne Proventa Critical Care Therapy System. The TriaDyne Proventa Critical Care Therapy System provides a comprehensive system of pulmonary and skin care therapies for the critically ill, immobilized patient.

    FDA Recall
    Terminated ·Arjo Hospital Equipment AB HANS MICHELSENSGATAN·Product code IKZ·December 3, 2014