Z-2718-2016Class II

ArjoHuntleigh Sara Combilizer; Intended to facilitate early immobilization, rehabilitation, and care of...

Name: Z-2718-2016 ArjoHuntleigh Sara Combilizer; Intended to facilitate early immobilization, rehabilitation, and care of...
Creator: ARJOHUNTLEIGH POLSKA Sp. z.o.o.
Published: 2016-06-29
License: https://open.fda.gov/license/

ArjoHuntleigh Polska Sp. zo.o. / initiated 2016-06-29 / Terminated / root cause: design

FDA source

ARJOHUNTLEIGH POLSKA Sp. z.o.o. began a recall of ArjoHuntleigh Sara Combilizer; Intended to facilitate early immobilization, rehabilitation, and care of patients on 2016-06-29. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2718-2016
Classification: Class II
Status: Terminated
Initiated: 2016-06-29
Posted: 2018-10-11
Terminated: 2019-03-08
Recalling firm: ArjoHuntleigh Polska Sp. zo.o.
Product: ArjoHuntleigh Sara Combilizer; Intended to facilitate early immobilization, rehabilitation, and care of patients.
Product code: INQ Table, Powered
Reason for recall: 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 tag: design
FDA 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 in commerce: 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.
Product codes and lots: 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 .

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2718-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2718-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-14	2016-09-02

Product code INQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)