Recall Z-2718-2016— ARJOHUNTLEIGH POLSKA Sp. z.o.o.

Class II FDA medical device recall by ARJOHUNTLEIGH POLSKA Sp. z.o.o., initiated 2016-06-29, terminated 2019-03-08. FDA's recall record names no specific 510(k) clearance for this event. Product: ArjoHuntleigh Sara Combilizer; Intended to facilitate early immobilization, rehabilitation, and care of patients.. Reason: 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)..

Recalling firm

ARJOHUNTLEIGH POLSKA Sp. z.o.o.

Classification

Class II

Status

Terminated

Initiated

2016-06-29

Terminated

2019-03-08

Firm location

KOMORNIKI, Poland

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