Trophy IRIX 70, IRIX 708, NOVELIX 6510 and ORAMATIC 558

Notice type: Advisory

Date: 30/07/2013


Product name or type:
Trophy IRIX 70, IRIX 708, NOVELIX 6510 and ORAMATIC 558


Manufacturer Or Supplier:
Carestream Health Inc.

Target Audience:
Dental hospital 
Dental Nurses 
Hospital CEOs 
Hospital Staff 
Clinical Risk Managers 
Clinical Nurse Managers 

Problem Or Issue:
The Scissor Arm bracket on these devices can break which could result in the arm falling.

Background Information Or Related Documents:
In 1995 and 2000 these scissor arms were subject to a recall modification intended to retain it in place, should the modified bracket break. Continued market surveillance of this product, including investigation of recent IRIX arm breakages, indicate that not all the affected units may have been modified as required. The attached Field Safety Notice (FSN) outlines the issue. A change in dealerships has resulted in poor records and poor tractability of the devices. The manufacturer, therefore, has requested the assistance of the Irish Medicines Board (IMB) in the communication of this issue.

Trophy IRIX 70, IRIX 708, NOVELIX 6510 and ORAMATIC 558 Document


Actions To Be Taken:
The IMB recommends that: 

1. Relevant personnel in your organisation are made aware of this potential issue. 
2. Examine your devices to determine if they are impacted by this issue. 
3. Check if your devices have been modified by following the instructions outlined in the attached FSN. 
4. For devices that have not been modified, remove them from service and contact Carestream. 
5. Ensure that this IMB Safety Notice and the attached FSN is passed on to any organisation or end user where the potentially affected devices have been transferred.

Further Information:
All adverse incidents relating to a medical device should be reported to the: 

Health Products Regulatory Authority
Kevin O’Malley House 
Earlsfort Centre 
Earlsfort Terrace 
Dublin 2 

Telephone: +353-1-6764971 
Fax: +353-1-6344033 

Enquiries to the manufacturer should be addressed to: 

Carestream Dental Technical support team 
Carestream Health Inc. 
150 Verona Street 
14608 Rochester, New York 

Telephone: 00 800 3456 6543 
Contact person: Kevin Wright 

Please click here to view a pdf version of this Safety Notice

Please click here to view the FSN

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