CHROMOPHARE Surgical Lighting System & CHROMOVIEW Flat Panel Monitor, Mechanical Spring Arms.

A mechanical failure of a welded joint within the spring Arm may result in the rapid drop of a monitor to the mechanical stop.

Berchtold issued a Product Safety Notification letter on November 16, 2009 identifying the affected device and issue prompting the action. Consignees were instructed to: Exercise caution when adjusting the position of the surgical lights or flat panel monitors. While an event is highly unlikely, the likelihood does increase when the spring arm is being repositioned. Identify a specific contact person for their facility to facilitate the communication and field action process with BERCHTOLD. The following action is being planned: To further identify if their units are part of the affected population, determine the supplier serial number identification and specific location for each spring arm in their facility. Report the facility information, supplier spring arm serial numbers and specific location or spring arms to a BERCHTOLD. Detail instructions on serial number identification and the method of reporting to BERCHTOLD will also be provided in a subsequent communication. Once BERCHTOLD has received the serial numbers of their spring arm assembly, customers will be notified whether their particular units are affected and the further required action. Berchtold Corporation can be contacted at 1 800 968 6097 about this action.