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Type of Product	Medical Device
TGA Recall Reference	RC-2023-RN-00967-1
Product Name/Description	ACROBAT-i Vacuum Positioner System Product code: XP-5000Z Lot Numbers: 3000195267, 3000195268, 3000195273, 3000195663, 3000199248, 3000199725, 3000204637, 3000207240, 3000211594, 3000212053, 3000213219, 3000214053, 3000214054, 3000214255, 3000221064, 3000214052, 3000225770, 3000226531, 3000225866, 3000225769, 3000231209, 3000231210 ARTG 157893 (Getinge Australia Pty Ltd - Patient positioning device vacuum stabilised partial body)
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	7/11/2023
Responsible Entity	Getinge Australia Pty Ltd
Reason/Issue	GETINGE is recalling certain lots of the Acrobat-i Vacuum Positioner System due to a risk that the Positioner Arm may not tighten or lock during normal use. If this issue occurs, the device must be replaced and there could be a potential procedural delay while a replacement is located, or a potential to convert surgery from an off-pump coronary artery bypass (OPCAB) to an on-pump surgical procedure. If the issue were to occur during a procedure, it could also result in hemodynamic instability and/or arrythmia. No adverse events have been reported to date related to this issue.
Recall Action	Recall
Recall Action Instructions	Customers should examine their inventory immediately to determine if they have any of the affected Acrobat-i Vacuum Positioner Systems with the product codes/lot numbers listed and remove these from use. Getinge will facilitate the removal of affected products from their facility and provide credit for return of these products. This action has been closed out on 1/3/2024.
Contact Information	1800 438 464 - Customer Service