Print version of this report

Type of Product	Medical Device
TGA Recall Reference	RC-2014-RN-00142-1
Product Name/Description	Kodak 2100 & 2200 Intraoral X-ray System (dental x-ray) 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. ARTG inclusion number: 136106
Recall Action Level	Retail
Recall Action Classification	Class II
Recall Action Commencement Date	10/02/2014
Responsible Entity	Carestream Health Australia Pty Ltd
Reason/Issue	Carestream Health Australia Pty Ltd has received advice that there were five incidents overseas where an early failure of the device occurred where pivot/bracket of the arm broke allowing the arm to drop to 90°.The failure is not immediate and would be noted by the user as part of the routine maintenance inspection, before the arm can fall. Should the arm fall, there is a risk of injury by impact to the patient or user.
Recall Action	Recall for Product Correction
Recall Action Instructions	To address this issue, a service engineer will attend the customer site, make a detailed inspection and install a bracket modification/replacement kit to address the problem. In the interim, customers are recommended to undertake regular inspections of their units to ensure that the arm has not failed. This action has been closed-out on 01/02/2016.
Contact Information	02 8962 4914 - Carestream Health Australia