Recall Z-0182-2009 ยท FQO Table, Operating-Room, Ac-Powered
Stryker Communications Corp
Circlip component of the Stryker Flat Panel and Navigation Arm System. Stryker Flat Panel and Navigation Arm System are intended for use as a ceiling-mounted device to support a medical grade flat panel monitor or camera in the patient area. The Circlip within the flat panel and navigation arms is part of the mechanical stop designed to prevent the arm from rotating infinitely. It also prevents t
| Date | Oct 22, 2008 (initiated Sep 5, 2008) |
| Status | Terminated |
| Reason | Circlip component used to suspend flat panel and navigation arm system may become dislodged. |
| Root cause | Device Design |
| Action | Notification letter was sent to consignees September 5, 2008. Field service will be performed at all affected sites. Old Circlips will be replaced with new clamps that do not allow the arm to fall. Contact Stryker Communications Corp. at 1-972-410-7310 for assistance. |
| Quantity | 705 units |
| Distribution | Nationwide and International Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.