Titan XL Handpiece Infrared Therapeutic Heating Lamp, Manufactured by Cutera Inc, Brisbane, CA Infrared therapeutic heat
FDA device recall Z-0329-2011 · posted 2010-11-09 · Terminated
Recall details
- Recalling firm
- Cutera Inc
- 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.
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- ILY
- Quantity affected
- 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, V
- Date initiated
- 2010-05-08
- Date posted
- 2010-11-09
- Date terminated
- 2010-12-28
- Location
- Brisbane, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CUTERA TABLETOP AESTHETIC PRODUCT (K042165) | Cutera, Inc. | 2004-10-18 |