| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00911-1 |
| Product Name/Description |
Sara Combilizer
(patient transfer lift)
Model Number: APA1000
Serial Numbers: P0299662, P0325930, P0325931 & P0325933
Manufactured between 16 May 2014 & 17 March 2016
ARTG Number: 199602 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
11/07/2016 |
| Responsible Entity |
|
| Reason/Issue |
It has been identified that a tipping hazard may occur on the current Sara Combilizer lifting mechanism, resulting in a potential risk to the patient or caregiver. 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°-28°. This scenario has been defined as highly unlikely to occur during use with patients. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Huntleigh Healthcare is arranging for an upgrade to the Sara Combilizer that involves the replacement of two parts of the lifting mechanism to ensure the device full stability. In the interim, Huntleigh Healthcare is advising users that the Combilizer can continue to be used until the upgrade is performed, on the condition that the tilt angle in the device "stretcher mode" will be no greater than 15° and the device is not loaded over 330 lbs (150 kg). An Addendum to the Instruction For Use that includes directions to ensure patient safety is also being provided to users. This action has been closed-out on 11/05/2017. |
| Contact Information |
08 9314 4102 - ArjoHuntleigh |