Leksell SurgiPlan
FDA device recall Z-1428-2010 · posted 2010-04-22 · Terminated
Recall details
- Recalling firm
- Elekta, Inc.
- Reason for recall
- Images from a different patient can be imported without a warning for the user.
- Action taken
- 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 elekta.com..
- Root cause
- Other
- Status
- Terminated
- Product code
- HAW
- Quantity affected
- 57 units
- Distribution
- Nationwide, Canada and Mexico.
- Date initiated
- 2005-05-23
- Date posted
- 2010-04-22
- Date terminated
- 2010-12-14
- Location
- Norcross, GA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LEKSELL SURGIPLAN (K943468) | Elekta Instruments, Inc. | 1995-01-20 |