FDA Device

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 usually used in cases involving stones anywhere from the bladder up to the kidneys. Occasionally the l

Hazard

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.

What You Should Do

Remedy

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 affected product, please send a copy of the Acknowledgement and Receipt Form to our Regulatory Department via fax at 510-832-1600 or via e-mail to regulatory@convergentlaser.com." If you have any further questions or concerns, please contact our Customer Service Department at 510-832-2130 or 800-848-8200.

Products

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 proc
Brand
Xintec Corp
UPC
all codes.

Units Affected

4343 units