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Type of Product Medical Device
TGA Recall Reference RC-2024-RN-00332-1
Product Name/Description Alphamaxx Operating Tables

Item number: 113322B4
Serial numbers: 3018 – 3078, 3080 – 3086, 3088, 3089, 3095 – 3097

Item number: 113322B5
Serial numbers: 2059 – 2118, 2119, 2120- 2183, 2185 – 2204, 2206, 2208, 2209, 2211-2231. 2233, 2235

Item number: 113322F5
Serial numbers: 409 – 411, 413 – 416

ARTG 163023
(Getinge Australia Pty Ltd - Table, operation, )
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 30/04/2024
Responsible Entity Getinge Australia Pty Ltd
Reason/Issue Getinge has identified that under certain circumstances a problem might prevent the device from performing as intended.

Batteries in affected devices may not be loaded completely by the charger unit. The required charging voltage is not provided during the charging period.
Recall Action Product Defect Correction
Recall Action Instructions The device can be used in accordance with the instructions for use, with extra attention to the following:
• The battery status is displayed on the override panel of the operating table (IFU113322XYEN18_01 § 4.3 Override control panel). This is visible to the user at any time.
• It is pointed out in the instruction for use (IFU113322XYEN18_01 § 5.2.4 Battery operation) that the operating table should be charged when the battery status is low.
Customer should maintain awareness of this notice and resulting action for the use period of the device to ensure effectiveness of the Product Defect Correction.
A solution that will correct this issue has been developed. Getinge will initiate an immediate field action of all affected device units. Customers will be contacted by Getinge sales or service representative to plan for the update of their device.

This action has been finalised on 29/7/2024.
Contact Information 1800 438 464 - Getinge Customer Service