Recall Z-1401-06 ยท IYE Accelerator, Linear, Medical
Siemens Medical Solutions USA, Inc
LANTIS XLINK (Impac MultiAccess Sequencer) on Varian accelerators with the MLC3PI interface
| Date | Aug 11, 2006 (initiated Jul 7, 2006) |
| Status | Terminated |
| Reason | Improper treatment may be delivered if the machine configuration file is edited/set for the Varian MLC revision H file format. |
| Root cause | Software design |
| Action | The firm has issued a safety advisory letter to all affected consignees, and will distribute an updated software version as soon as it is available. |
| Quantity | 23 units |
| Distribution | Worldwide Distribution --- USA and countries including Australia, China, Denmark, Germany, New Zealand, Portugal, Russia, Singapore, South Africa, Sweden and Switzerland |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K981313 | SEQUENCER Impac Medical Systems, Inc., Jul 9, 1998 |