FDA Medical Device Recalls (openFDA)
ARJOHUNTLEIGH POLSKA Sp. z.o.o.: ArjoHuntleigh Sara Combilizer; Intended to facilitate early immobilization, rehabilitation, and care of patients.
- Recall number
- Z-2718-2016
- Recalling firm
- ARJOHUNTLEIGH POLSKA Sp. z.o.o.
- Product
- ArjoHuntleigh Sara Combilizer; Intended to facilitate early immobilization, rehabilitation, and care of patients.
- Status
- Terminated
- Initiated
- 2016-06-29
- Posted
- not on file
- Terminated
- 2019-03-08
- 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).
- 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.
- Lot, serial or model codes
- Device Listing Number E101987, Model Number APA1000-XX; Serial numbers P0359671 , P0360103 , P0338345 , P0354548 , P0357690 , P0359672 , P0359673 , P0348548 , P0349629 , P0361336 , P0361337 , P0361875 , P0361876 , P0361877 , P0360104 , P0360105 , P0346000 , P0373592 , P0357691 , P0349634 , P0354549 , P0349627 , P0339257 , P0321458 , P0299662 , P0325930 , P0325931 , P0325933 , P0310854 , P0344175 , P0356357 , P0356362 , P0356363 , P0360990 , P0375493 , P0298175 , P0309635 , P0310848 , P0323622 , P0323624 , P0325167 , 1404000118 , P0296131 , P0296315 , P0298465 , P0319583 , P0333285 , P0333288 , P0339264 , P0343583 , P0343584 , P0343585 , P0343684 , P0344174 , P0353246 , P0364628 , 1404000112 , P0333284 , P0333290 , P0294982 , P0294983 , P0295762 , P0298158 , P0309472 , P0317162 , P0325970 , P0331310 , 1404000113 , 1404000119 , 1404000120 , P0325967 , P0332385 , P0333283 , P0339574 , P0296130 , P0296318 , P0321460 , P0332383 , 1404000115 , P0331312 , P0331311 , P0331318 , P0331319 , P0325968 , P0295846 , P0294981 , P0294985 , P0295847 , P0332386 , P0294984 , P0332384 , 1404000116 , 1404000117 , P0321461 , 1404000114 , P0294986 , P0298176 , P0323011 , P0361422 , P0361423 , P0363456 , P0357692 , P0360102 , P0328718 , P0328720 , P0328724 .
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- INQ
- Firm FEI
- 3007420694
- Firm city
- KOMORNIKI
- Firm state
- not on file
- Firm country
- Poland
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28