Luxtec MLX 300 Watt Xenon Light Source, Model OOMLX; Surgical/Medical Light Source This light source is designed to supp

FDA device recall Z-2060-2011 · posted 2011-04-25 · Terminated

Recall details

Recalling firm

Integra LifeSciences Corp.

Reason for recall

Malfunction of the MLX Control Board may cause loss of manual control and Lamp shut down.

Action taken

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

Status

Terminated

Product code

FCW

Quantity affected

159 units

Distribution

Nationwide, Canada, Australia, Germany, Netherlands, New Zealand, Norway, Singapore and Sweden

Date initiated

2011-03-07

Date posted

2011-04-25

Date terminated

2014-03-26

Location

Plainsboro, NJ

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