Recall Z-0591-2011 ยท FTD Lamp, Surgical
Berchtold Corp.
CHROMOPHARE Surgical Lighting System & CHROMOVIEW Flat Panel Monitor, Mechanical Spring Arms.
| Date | Dec 10, 2010 (initiated Nov 16, 2009) |
| Status | Terminated |
| Reason | A mechanical failure of a welded joint within the spring Arm may result in the rapid drop of a monitor to the mechanical stop. |
| Root cause | Other |
| Action | 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 pop |
| Quantity | 7031 arms |
| Distribution | Worldwide Distribution: Throught the U.S,.and the countries of Canada and Germany |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K922836 | CHROMOPHARE Berchtold Holding GmbH, Oct 9, 1992 |