Recall Z-0329-2011 ยท ILY Lamp, Infrared, Therapeutic Heating
Cutera Inc
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.
| Date | Nov 9, 2010 (initiated May 8, 2010) |
| Status | Terminated |
| Reason | Risk of burns-- under certain conditions, devices containing a gold plated end block could produce energy above what is stated on the device setting. |
| Root cause | 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 | 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, Ber |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042165 | CUTERA TABLETOP AESTHETIC PRODUCT Cutera, Inc., Oct 18, 2004 |