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.
This recall has been terminated (originally issued November 9, 2010).
- Company
- Cutera, Inc.
- Recall Initiated
- May 8, 2010
- Posted
- November 9, 2010
- Terminated
- December 28, 2010
- Recall Number
- Z-0329-2011
- Quantity
- 1,344 units
- Firm Location
- Brisbane, CA
- Official Source
- View on FDA website ↗
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.
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.
Lot / Code Info
All products manufactured before October 1, 2009 with gold plated end blocks.
Root Cause
Device Design
Action Taken
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.