ArjoHuntleigh Sara Combilizer; Intended to facilitate early immobilization, rehabilitation, and care of patients.
FDA Recall Z-2718-2016 · Posted None
Recalling FirmARJOHUNTLEIGH POLSKA Sp. z.o.o.
Recall StatusTerminated
Product CodeINQ
Date Initiated2016-06-29
Date Terminated2019-03-08
Product Quantity106
Reason for Recall
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).
Firm Action
A Field Safety Notice, a Customer Response Form and the Sara Combilizer
Addendum to the Instructions For Use (IFU) will be mailed to all affected customers.
Root Cause
Device Design
Distribution Pattern
CO, AL, MA, NC, MI, NY, FL, MD, CA, VA, CT, TX, and IL; Australia, Austria, Denmark, Germany, Israel, Japan, Norway, Sweden, Switzerland, UAE, and UK.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.