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U.S. Department of Health and Human Services

Class 2 Device Recall Titan XL

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  Class 2 Device Recall Titan XL see related information
Date Initiated by Firm May 08, 2010
Date Posted November 09, 2010
Recall Status1 Terminated 3 on December 28, 2010
Recall Number Z-0329-2011
Recall Event ID 55840
510(K)Number K042165  
Product Classification Lamp, infrared, therapeutic heating - Product Code ILY
Product Titan XL Handpiece Infrared Therapeutic Heating Lamp, Manufactured by Cutera Inc, Brisbane, CA
Infrared therapeutic heating lamp, intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness.
Code Information All products manufactured before October 1, 2009 with gold plated end blocks.
Recalling Firm/
Manufacturer		 Cutera Inc
3240 Bayshore Blvd
Brisbane CA 94005
For Additional Information Contact
415-657-5586
Manufacturer Reason
for Recall		 Risk of burns-- under certain conditions, devices containing a gold plated end block could produce energy above what is stated on the device setting.
FDA Determined
Cause 2		 Device Design
Action Cutera sent Certified letters sent to all consignees on May 8, 2010. The letter identified the product, the problem, and the action the consignees should take. Consigness were instructed to immediately stop using the handpiece and complete the attached Recall Tracker Form. A second letter was sent to customers who received a replacement handpiecce but did not return the affected devices. All affected products were to be exchanged for new or reworked devices. For questions contact customer service at (888) 428-8372, ext 5561.
Quantity in Commerce 1,344 units
Distribution Worldwide Distribution - USA including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OK, OR, PA, OH, SC, TN, TX, UT, VA, VT, WA, WI, WV, AND WY and the countries of Argentina, Australia, Austria, Barbados, Belgium, Bermuda, Brazil, Bulgaria, Canada, Chile, China, Columbia, Croatia, Cypress, Denmark, Dominican Republic, Egypt, Finland, France, Germany, Greece, Guadeloupe, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Japan, Lle de la Reunion, Mexico, New Zealand, Phillipines, Poland, Puerto Rico, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Switzerland, Thailand, Turkey, UAE, and Ukraine.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = ILY and Original Applicant = CUTERA, INC.
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