Lumenis Limited

3 recalls •

• Categories: Infusion Pumps, Other Medical Devices, Surgical Instruments

FemTouch delivery system includes the FemTouch Kit (AC-1007415) and FemTouch" Tip (SPSA-20002590) Provide fractional treatments in gynecology.

Class I - Dangerous

The cleaning instructions provided in FemTouch Operator's Manual might be ineffective for a fully assembled device and may lead to a potential for cross-contamination.

Sep 25, 2016 Infusion Pumps View Details →

Light Sheer Desire Diode Laser System with XC Handpiece Accessory options.

Class I - Dangerous

Device software treatment preset parameters for the XC treatment handpiece do not match the Operator Manual, and exceed recommended settings. Operator Manual parameters are lower than indicated for specific hair color and Fitzpatrick skin type resulting in insufficient treatment effect. May result in patient burns and hypopigmentation.

Mar 25, 2015 Other Medical Devices Nationwide View Details →

The Lumenis VersaCut Tissue Morcellator Product Usage: is intended for use under direct or endoscopic visualization for the morcellation and removal of dissected tissue during pelviscopic, laparoscopic, percutaneous, and open surgical procedures whenever access to the surgical site is limited.

Class I - Dangerous

Lumenis Ltd is recalling certain models of VersaCut Morcellator devices to perform corrective labeling as a result of three reported events of air embolism secondary to incorrect reversal tubing system hook-up.

Jan 2, 2013 Surgical Instruments Nationwide View Details →