Recall Z-1624-2012 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Ellman International, Inc.
Pelleve Non-Ablative Wrinkle Treatment Handpiece, Product Codes D110FSHP, D115FSHP (reusable) --- Pelleve --- Elegance through science --- Contents: One (1) Pelleve Handpiece (Reusable) --- Non-ablative treatment of mild to moderate facial wrinkles and rhytids for skin phototypes I-IV.
| Date | May 17, 2012 (initiated May 4, 2012) |
| Status | Terminated |
| Reason | Ellman International is recalling its Pelleve reusable handpiece because of possible cable failure and sparking. |
| Root cause | Equipment maintenance |
| Action | Ellman will notify all consignees initially via UPS shipment with an Urgent: Medical Device Recall letter containing notification of the recall and instructions. The letter identifies the affected product, problem, and instructs customers to identify and return the handpieces in the enclosed prepaid mailer. Customers are to complete and return the Product Recall Verification Form and fax it to the number provided. In addition, customers are provided with a toll-free number, 1-877-522-7141, to call in the event that they have questions or require additional instruction. Customers will initia |
| Quantity | 1,088 units |
| Distribution | Worldwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082834 | ELLMAN INTERNATIONAL NON-ABLATIVE TECHNIQUE FOR SURGITRON IEC Ellman Int'L, Inc., May 7, 2009 |