ArjoHuntleigh Sara Combilizer Recalled for Potential Tipping Hazard
ArjoHuntleigh is recalling 106 Sara Combilizer patient lifts due to a potential tipping hazard identified during internal testing. No adverse events or customer complaints have been reported to date.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (patient lift tipping) where injury has not yet been reported, which aligns with the High severity criteria for theoretical hazards without reported illness or injury.
Plain-English summary
ArjoHuntleigh Polska Sp. z.o.o. is recalling 106 units of the Sara Combilizer patient lift, model APA1000-XX. The device is intended to facilitate early immobilization, rehabilitation, and care of patients. The recall is due to a potential tipping hazard in the lifting mechanism that was identified during internal device testing.
The tipping hazard may occur when a fully loaded device in "stretcher mode" is lifted to the highest position (approximately 984 mm or 38 3/4 inches) and tilted backwards to an angle of 25 to 28 degrees. Although this scenario is defined as highly unlikely to occur during use with patients, the company is providing this information as a commitment to quality. To date, there have been no adverse events or customer complaints related to this phenomenon.
The affected devices were distributed in the United States (CO, AL, MA, NC, MI, NY, FL, MD, CA, VA, CT, TX, and IL) and internationally (Australia, Austria, Denmark, Germany, Israel, Japan, Norway, Sweden, Switzerland, UAE, and UK). Customers may continue to use the device until an upgrade is performed, provided the tilt angle in "stretcher mode" is no greater than minus 15 degrees and the device is not loaded over 330 lbs (150 kg).
The recalled product
- Product
- ArjoHuntleigh Sara Combilizer; Intended to facilitate early immobilization, rehabilitation, and care of patients.
- Manufacturer
- ARJOHUNTLEIGH POLSKA Sp. z.o.o.
- Category
- Medical Device — Patient Lift
- Hazard
- Affected units
- 106
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
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