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Type of Product	Medical Device
TGA Recall Reference	RC-2015-RN-00073-1
Product Name/Description	CS 8100 & CS 8100 3D (A diagnostic dental x-ray system) Serial numbers starting WEYA618-627, WF, WG, WH, WI, WJ, WK, WL, XA, XB, XC, XD, XE, XF, XG, XH, XI, XJ, XK, XL, YA, YB, YC, YD. Manufacturing Date: June 2012 to September 2014 ARTG Number: 136114 and 136106
Recall Action Level	Retail
Recall Action Classification	Class I
Recall Action Commencement Date	29/01/2015
Responsible Entity	Carestream Health Australia Pty Ltd
Reason/Issue	Carestream Health Australia Pty Ltd has received a report that the column of a CS 8100 demonstration device descended unexpectedly as one of the two retaining clips (circlips) that holds the locating pin in place was missing. If a circlip is not placed on both ends of the locating pin, it is possible that movement and transport of a unit can cause the pin to move out of position, or fall out completely. Testing showed the device operation could appear normal for several lifting cycles after the pin fell out completely due to friction holding the ends of two units together, but the jack would eventually slip off the base plate stand. No other reports, complaints or injuries of this type (related to missing circlip) have been received since the device was introduced into commercial distribution in 2012.
Recall Action	Recall for Product Correction
Recall Action Instructions	Carestream Health Australia is organising a service call and a service engineer will attend the user’s site, make a detailed inspection and replace the column assembly if required. This action has been closed-out on 24/05/2016.
Contact Information	1300 651 786 - Carestream Health Australia