Recall Z-1428-2010 ยท HAW Neurological Stereotaxic Instrument
Elekta, Inc.
Leksell SurgiPlan
| Date | Apr 22, 2010 (initiated May 23, 2005) |
| Status | Terminated |
| Reason | Images from a different patient can be imported without a warning for the user. |
| Root cause | Other |
| Action | Phase I - A technical note for LGP and SPS describing the risk for importing wrong image files and including recommendations on how to reduce this risk has been written and distributed to users of both Leksell GammaPlan and Leksell SurgiPlan on May 23, 2005 via FCO DOC 05-0001. Phase 2 - A maintenance release was created of the Scanner Interface (SIF) to correct the problem. This was distributed to Leksell SurgiPlan users on November 30, 2005 via FCO0000153-1. Additional questions are directed to the firm to Product Manager lrobert.aslund AT elekta.com, or After Sales gustaf.piehl AT elek |
| Quantity | 57 units |
| Distribution | Nationwide, Canada and Mexico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K943468 | LEKSELL SURGIPLAN Elekta Instruments, Inc., Jan 20, 1995 |