Recall Z-2060-2011 ยท FCW Light Source, Fiberoptic, Routine
Integra LifeSciences Corp.
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.
| Date | Apr 25, 2011 (initiated Mar 7, 2011) |
| Status | Terminated |
| Reason | Malfunction of the MLX Control Board may cause loss of manual control and Lamp shut down. |
| Root cause | Process change control |
| 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 s |
| Quantity | 159 units |
| Distribution | Nationwide, Canada, Australia, Germany, Netherlands, New Zealand, Norway, Singapore and Sweden |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081477 | LUXTEC MLX LIGHT SOURCE Integra Luxtec, Inc., Jun 18, 2008 |