Recall Z-0850-2008 ยท IYE Accelerator, Linear, Medical
Siemens Medical Solutions USA, Inc
Siemens Primus Linear Accelerator System, PRIMART MX Linear Accelerator System; PRIMUS Mid, Part Number:1940035 and PRIMART MX, Part Number: 5500371, Siemens Medical Solutions USA, Inc., Concord, CA
| Date | Feb 19, 2008 (initiated Jul 27, 2007) |
| Status | Terminated |
| Reason | Door Hinge failures; loose or falling off (Stationary Structure Doors) |
| Root cause | Component design/selection |
| Action | Stationary Door Hinges will be replaced on each device by the recalling firm's technician visits. |
| Quantity | 1,284 total for recalls Z-0850-0852-2008 |
| Distribution | Worldwide- 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 record | Open on fda.gov |
510(k) clearances named in this recall
| K993425 | PRIMUS Siemens Medical Solutions USA, Inc., Nov 26, 1999 |