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Type of Product Medical Device
TGA Recall Reference RC-2016-RN-00247-1
Product Name/Description NIM-ECLIPSE Notebook Computer, NCCPU-E4
(Part of the NIM-ECLIPSE System used for neurovascular monitoring during intraoperative and ICU applications)

Lot / Batch numbers:
X06016674, X06016675, X06018893, X06026959,
X06026960, X06026961, X06026962, X06026963,
X06040001, X06040002, X06042171, X06042172,

ARTG number: 169810
Recall Action Level Hospital
Recall Action Classification Class III
Recall Action Commencement Date 8/03/2016
Responsible Entity Medtronic Australasia Pty Ltd
Reason/Issue Two laptops returned from Medtronic Japan distribution centre alleged a power supply issue. The defective power supply could impact the performance of the GUI by introducing latency (delay) in its performance. However, once the units are turned on while connected to their respective power supplies (Dell 90 Watt AC adapters), the users would be warned by the "AC Alert Message" that is shown on the screen during the boot up process.

This issue is unlikely to present a hazard to either the patient or the user. There have been no complaints or adverse events reported for this issue from the field.
Recall Action Recall for Product Correction
Recall Action Instructions Medtronic will replace the affected power supply units with unaffected stock. This action has been closed-out on 27/01/2017.
Contact Information 07 3025 3549 - Medtronic