My HPRA: Register

Kodak 2100 and 2200

Notice type: Advisory

Date: 19/02/2014

  

Product name or type:
Kodak 2100 and 2200

Reference:
SN2014(03)

Manufacturer Or Supplier:
Carestream Health Inc.

Target Audience:
Dentists 
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:
Kodak 2100 and Kodak 2200 Intraoral Dental X-Ray Systems released for sale between May 2008 and April 2010 possess the potential for early failure and breakage of the scissor arm to bracket connection. The failure is not immediate and normally is visible to the user before the arm can fall. Should the arm fall, there is a risk of injury by impact to patient or user. The manufacturer has released the attached field safety notice (FSN) highlighting this issue and advising that users make regular inspections. However not all distributors have responded to requests for confirmation of its distribution throughout the Irish market. The manufacturer, therefore, has requested the assistance of the Irish Medicines Board (IMB) in the communication of this issue. Carestream is performing a field safety corrective action to have each unit within the affected period inspected on site by an engineer and a modification added to each unit.

Kodak 2100 and 2200 Document

Actions To Be Taken:
The IMB recommends that: 

1. Examine your devices using the pictures contained in the FSN as reference, and ensure the arm has not failed. 

2. If the unit shows early signs of failure at inspection, please stop using it and call your dealer immediately. A service engineer from your dealer will visit to make a detailed inspection and a modification to rectify the problem. 

3. 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 
E-mail: devicesafety@hpra.ie
Website: www.hpra.ie 

Enquiries to the manufacturer should be addressed to: 

Carestream Health Inc. 
150 Verona Street 
14608 Rochester 
New York 
USA 

Telephone: 00800 4567 7654 

 
Please click here to view a PDF version of the safety notice

Please click here to view a copy of the field safety notice

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