Luxtec MLX 300 Watt Xenon Light Source, Model OOMLX; Surgical/Medical Light Source This light source is designed to supply high-intensity light to a fiber optic cable for illumination of a surgical field during a surgical and/or medical procedure.
FDA Recall Z-2060-2011 · Posted 2011-04-25
Recalling FirmIntegra LifeSciences Corp.
Recall StatusTerminated
Product CodeFCW
Date Initiated2011-03-07
Date Terminated2014-03-26
Product Quantity159 units
Reason for Recall
Malfunction of the MLX Control Board may cause loss of manual control and Lamp shut down.
Firm Action
Integra notified all customers/distributors via written communication, dated 3/08/2011. On 3/09/11, Integra Sales Representatives and Service Technicians were notified via telephone conference call and provided copies of written communications. Customers were advised to immediately discontinue use of any affected product and to place in a secure area. Note: This defect only applies to MLX units that were repaired between 12/01/2009 and 1/31/2011. This defect does not occur in manufactured units that have not been serviced, nor does it apply to MLX units that were serviced outside of this specific timeframe. Customers with devices already known to require repair and/or servicing will be contacted directly to arrange for the return of their device(s). Additionally, sales specialists were instructed to examine each customer's inventory for those device(s) that may potentially have the jumper-wire and to perform a stand-by test to determine if repair and/or servicing are required.
Root Cause
Process change control
Distribution Pattern
Nationwide, Canada, Australia, Germany, Netherlands, New Zealand, Norway, Singapore and Sweden
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.