Recall Z-2718-2016 ยท INQ Table, Powered
ARJOHUNTLEIGH POLSKA Sp. z.o.o.
ArjoHuntleigh Sara Combilizer; Intended to facilitate early immobilization, rehabilitation, and care of patients.
| Date | Jun 29, 2016 |
| Status | Terminated |
| 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 define |
| Root cause | Device Design |
| 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. |
| Quantity | 106 |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.