ArjoHuntleigh Sara Combilizer; Intended to facilitate early immobilization, rehabilitation, and care of patients.
Recall
- Recall Number
- Z-2718-2016
- Event Number
- 74506
- Firm
- ARJOHUNTLEIGH POLSKA Sp. z.o.o. UI. KS. PIOTRA WAWRZYNIAKA 2 KOMORNIKI Poland
- FEI Number
- 3007420694
- Product Code
- INQ
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- June 29, 2016
- Terminated
- March 8, 2019
Description
ArjoHuntleigh Sara Combilizer; Intended to facilitate early immobilization, rehabilitation, and care of patients.
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).
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.
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.
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