Reported Sep 14, 2016 · Terminated
ArjoHuntleigh Sara Combilizer; Intended to facilitate early immobilization, rehabilitation, and care of patients.
ARJOHUNTLEIGH POLSKA Sp. z.o.o.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: ARJOHUNTLEIGH POLSKA Sp. z.o.o. · UI. KS. PIOTRA WAWRZYNIAKA 2 · KOMORNIKI · N/A
Is this the product you have?
- ArjoHuntleigh Sara Combilizer; Intended to facilitate early immobilization, rehabilitation, and care of patients.
- Lot codes and dates
108 of 108 codes
Device Listing Number E101987Model Number APA1000-XXSerial numbers P0359671P0360103P0338345P0354548P0357690P0359672P0359673P0348548P0349629P0361336P0361337P0361875P0361876P0361877P0360104P0360105P0346000P0373592P0357691P0349634P0354549P0349627P0339257P0321458P0299662P0325930P0325931P0325933P0310854P0344175P0356357P0356362P0356363P0360990P0375493P0298175P0309635P0310848P0323622P0323624P03251671404000118P0296131P0296315P0298465P0319583P0333285P0333288P0339264P0343583P0343584P0343585P0343684P0344174P0353246P03646281404000112P0333284
- Amount recalled
- 106
Where it was sold
Why it was recalled
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).
This product could cause temporary or reversible health problems — stop using it.
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