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.
Other recalls by Arjohuntleigh Polska Sp Z O O
- Arjo Tenor mobile passive patient lift, Model Numbers KHA1000 US and KHA1010 US
FDA Device · Class II · 2026-04-22 · Arjohuntleigh Polska Sp Z O O - Arjo medical beds, Models Enterprise 5000X, Enterprise 8000X, Enterprise 9000X and Citadel, assembled with IndiGo Drive Assistance module a…
FDA Device · Class II · 2024-01-03 · Arjohuntleigh Polska Sp Z O O - Arjo medical beds, Models Enterprise 5000X, Enterprise 8000X, Enterprise 9000X and Citadel, assembled with IndiGo Drive Assistance module a…
FDA Device · Class II · 2024-01-03 · Arjohuntleigh Polska Sp Z O O - Sara Plus Active Floor Lift
FDA Device · Class I · 2022-06-01 · Arjohuntleigh Polska Sp Z O O - Arjo Citadel beds originally assembled with the IndiGo modules during manufcturing, model number CX812A3J3AMAD0
FDA Device · Class II · 2021-10-06 · Arjohuntleigh Polska Sp Z O O
All Arjohuntleigh Polska Sp Z O O recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2718-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.