Recall Z-2866-2017 ยท GEX Powered Laser Surgical Instrument
Xintec Corp
OptiLITE(TM) Products for Laser Surgery, Catalog Numbers: HTM1020F, HTM1040F, HTM1060F, HTM1010F; Manufactured by CONVERGENT LASTER TECHNOLOGIES The Odyssey 30B is approved for numerous medical procedures. Generally, the primary use of the laser (which includes the fibers) is related to urology, but ultimately it is up to the surgeon except in cases where it is contraindicated. The fibers are
| Date | Jun 23, 2017 |
| Status | Terminated |
| Reason | It has been determined that the reprocessing instructions may not provide sufficiently detailed information for the cleaning, disinfection and sterilization of the products listed below. The preliminary investigation indicates that validation data related to the reprocessing of these devices may not meet newly enacted standards. |
| Root cause | Labeling False and Misleading |
| Action | The firm, Convergent Laser Technologies, sent an "URGENT - MEDICAL DEVICE RECALL" letter dated 06/23/2017 to its Consignees. The letter described the product, problem and actions to be taken. The consignees were instructed as follows: "Please immediately review your inventory and quarantine any affected product. Please return any affected products within 30 days according to the instructions provided in the attached Acknowledgement and Receipt Form. Upon receipt of the product and response form, we will arrange for a credit to your account. Also, whether or not you are returning any affect |
| Quantity | 4343 units |
| Distribution | Worldwide distribution- US (Nationwide) and countries of: Canada and Sri Lanka. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K992866 | OPTILITE IX LASER SURGERY ACCESSORIES Convergent Laser Technologies, Nov 18, 1999 |