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Marus Brand LuxStar Dental Lights

Notice type: Advisory

Date: 16/11/2011

  

Product name or type:
Marus Brand LuxStar Dental Lights

Reference:
SN2011(26)

Manufacturer Or Supplier:
Marus, USA

Target Audience:
Dental Practitioners 
Distributors

Problem Or Issue:
Marus has become aware that the lens heat (bulb) shield (birdcage) on the Marus LuxStar dental lights, model OL1000, may potentially fall off the dental light if not properly installed after replacing the light bulb, or if not properly maintained.

Background Information Or Related Documents:
Marus has issued a field safety notice (see attached) and has developed a self install kit, which will mitigate the risks associated with this issue.

Marus Brand LuxStar Dental Lights Document

Actions To Be Taken:
Marus has been unsuccessful in their attempts to locate all devices affected by this field safety corrective action (FSCA), as one of the distributors in Ireland, Dacus Dental, has ceased trading. The serial numbers of the devices provided to Dacus Dental are 4714B and 165569B. 

The IMB advises that users: 

• Identify the affected devices in your facility. 
• Ensure the appropriate personnel are made aware of this notice. 
• If you (or your facility) have affected devices, follow the recommendations outlined in the attached Field Safety Notice and contact Marus to obtain the self-installation kit. 

Further Information:
Enquiries to the Manufacturer / European authorised representative should be addressed to: 

Ms. Bonnie Dundas 
Quality Assurance and Regulatory Affairs Manager 
Marus 
705 S. Springbrook Rd., Building C 
Newberg, OR 97132 
U.S.A. 

Telephone: +1 503 537 3602 
Fax: +1 503 537 3617 
E-mail: bonnie.dundas@marus.com 

Ms. Lorna Sanderson 
Medical Device & QA Services Ltd. 
76, Stockport Road 
Timperley, Cheshire 
WA15 7SN 
United Kingdom 

Telephone: +44 161 870 6751 
Fax: +44 161 903 9787 
E-mail: lorna@mdqa.co.uk 

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: vigilance@imb.ie 
Website: www.hpra.ie 

Please click here to download a PDF copy of this Safety Notice

Please click here to download the Field Safety Notice

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