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Type of Product	Medical Device
TGA Recall Reference	RC-2017-RN-01286-1
Product Name/Description	Ceiling Unit CU5001/3 and CU 3-21/23 Product Code: CU 5001 Reference Number: 604 105 Serial Numbers: from P51 up to 274 Product Code: CU 5003 Reference Number: 604 106 Serial Numbers: from P51 up to 127 Product Code: CU 3-21 Reference Number: 604 650 Serial Numbers: from P51 up to P58 Product Code: CU 3-23 Reference Number: 604 700 Serial Numbers: from P51 up to P60 ARTG Number: 267878
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	13/10/2017
Responsible Entity	Device Technologies Australia Pty Ltd
Reason/Issue	The microscope arm of specific ceiling units can be electrically driven from the parked position into the operating field by an electromotive lifting column. The manufacturer Moller-Wedel has identified that abrasive wear of the drive assembly can occur which could cause a slide-through of the telescopic column into the lowest stop. The microscope arm can be moved upwards and downwards with a levitation height of 40cm by a motorised adjusted telescopic column. If severe abrasive wear occurs the lifting column can slide downwards during lifting procedures up to 40cm onto the lowest stop.
Recall Action	Recall for Product Correction
Recall Action Instructions	Device Technologies is advising users to move the telescope column to the lowest position for use without restrictions. Users should attach provided labels to the ceiling unit to indicate that the lifting column is in the lowest position until service has been performed. This action has been reviewed and is considered complete in accordance with the requirements of the URPTG.
Contact Information	03 9371 0973 - Device Technologies Australia