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Type of Product	Medical Device
TGA Recall Reference	RC-2018-RN-00282-1
Product Name/Description	Getinge VOLISTA StandOP and TRIPOD surgical lights Model Codes: VOLISTA 400 and VOLISTA 600 Manufactured before June 2017 Keypad Part Number: ARD568801560 Up to Serial Number: 540000 Device Part Numbers: ARD568811950, ARD568811960, ARD568811961, ARD568811962, ARD568812910, ARD568812950, ARD568812960, ARD568812962, ARD568821913, ARD568821960, ARD568821963, ARD568822960, ARD568822963 ARTG Number: 162037 (Getinge Australia - Light, surgical)
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	27/03/2018
Responsible Entity	Getinge Australia Pty Ltd
Reason/Issue	Getinge has identified an issue causing failure of the control keypad resulting in the cupola not turning on or off. A review of complaint data has demonstrated that this issue has occurs in 3 different keypad versions. This potential for malfunction is caused by an internal frequency issue of a component on keypads version 1, and by the touch-sensitive technology that was not sensitive enough on versions 2 and 3. The keypads at fault are no longer produced. Getinge have implemented a more robust keypad using a different technology. This action is to replace the potentially defective keypads with the new keypad. To date, no injuries as a result of this issue have been reported.
Recall Action	Product Defect Correction
Recall Action Instructions	Getinge is advising they will contact affected users to schedule a service to replace any potentially defective keypads with the new keypad. This action has been closed out on 18/02/2019
Contact Information	1800 438 464 - Getinge Customer Service