Z-2866-2017Class II

OptiLITE(TM) Products for Laser Surgery, Catalog Numbers: HTM1020F, HTM1040F, HTM1060F, HTM1010F...

Name: Z-2866-2017 OptiLITE(TM) Products for Laser Surgery, Catalog Numbers: HTM1020F, HTM1040F, HTM1060F, HTM1010F...
Creator: Xintec Corp
Published: 2017-06-23
License: https://open.fda.gov/license/

Xintec Corporation / initiated 2017-06-23 / Terminated / root cause: labeling and UDI

FDA source

Xintec Corp began a recall of OptiLITE(TM) Products for Laser Surgery, Catalog Numbers: HTM1020F, HTM1040F, HTM1060F, HTM1010F; Manufactured by CONVERGENT LASTER TECHNOLOGIES The Odyssey... on 2017-06-23. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2866-2017
Classification: Class II
Status: Terminated
Initiated: 2017-06-23
Posted: 2017-08-02
Terminated: 2018-06-20
Recalling firm: Xintec Corporation
Product: 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 laser system is used in soft tissue cases (non-cancerous tumors) in and around the urinary system.
Product code: GEX Powered Laser Surgical Instrument
Reason for recall: 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 tag: labeling and UDI
FDA 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 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 [email protected]." If you have any further questions or concerns, please contact our Customer Service Department at 510-832-2130 or 800-848-8200.
Quantity in commerce: 4343 units
Distribution: Worldwide distribution- US (Nationwide) and countries of: Canada and Sri Lanka.
Product codes and lots: all codes.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2866-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2866-2017	Class II	Terminated	Voluntary: Firm initiated	2017-08-09	2017-08-02

Product code GEX

K992866Class IIOptilite IX Laser Surgery AccessoriesConvergent Laser Technologies / cleared 1999-11-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)