ClearanceBrief
Recall Z-0851-2008 ยท IYE Accelerator, Linear, Medical

Siemens Medical Solutions USA, Inc

Siemens Mevatron Linear Accelerator Systems: KD2, K 7767, K 8067, KD, KDS and KDS2, Mevatron KD2, Part No.: 1940753; Mevatron KD2, Part No.: 08515520; Mevatron KD2-Part No.: 9822685; Mevatron K 7767, Part No.: 5694302; Mevatron K 8067, Part No.: 5694401; Mevatron KD, Part No.: 8319857; Mevatron KDS, Part No.: 9401522; Mevatron KDS2, Part No.: 9411588; and Mevatron KDS2, Part No.: 9822693, Siemens

DateFeb 19, 2008 (initiated Jul 27, 2007)
StatusTerminated
ReasonDoor Hinge failures; loose or falling off (Stationary Structure Doors)
Root causeComponent design/selection
ActionStationary Door Hinges will be replaced on each device by the recalling firm's technician visits.
Quantity1,284 total for recalls Z-0850-0852-2008
DistributionWorldwide- USA including the states of Missouri, Georgia, Delaware, Texas, Ohio, Alabama, Kentucky, Florida, California, North Carolina, New Jersey, New York, Illinois, Pennsylvania, Colorado, Tennessee, Arizona, Pennsylvania, Virginia, New Jersey, Michigan, Wisconsin, Indiana, Nebraska, Montana, Ka
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K862339MEVATRON KD-2
Siemens Medical Laboratories, Inc., Oct 29, 1986