FDA Device recall Z-2718-2016
ArjoHuntleigh Sara Combilizer
- FDA Device
- Class II
- terminated
- Published 2016-09-14
On 2016-09-14 the FDA classified a Class II recall of ArjoHuntleigh Sara Combilizer by Arjohuntleigh Polska Sp Z O O, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2718-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-06-29 |
| Published | 2016-09-14 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Arjohuntleigh Polska Sp Z O O |
| Distribution | AL, CA, CO, CT, FL, IL, MA, MD, MI, NC, NY, TX, VA |
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).
Identifiers
| code_info | Device Listing Number E101987, Model Number APA1000-XX; Serial numbers P0359671 , P0360103 , P0338345 , P0354548 ,…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 , P0321 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2718-2016%22
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