Leksell Gamma Knife Perfexion. Radionuclide radiation therapy system. Elekta, Inc. Norcross, GA. Indicated for use in th
FDA device recall Z-1231-2010 · posted 2010-04-05 · Terminated
Recall details
- Recalling firm
- Elekta, Inc.
- Reason for recall
- There has been an issue with "Image Fushing" where low precision calculation caused images to become inaccurate.
- Action taken
- Elekta, Inc. issued a Field Change Order, Reference Number 0000946 dated March 14, 2008. Consignees were informed of the affected product and instructed on necessary steps to take. For further information, contact Elekta, Inc. at 1-770-300-9725.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IWB
- Quantity affected
- 18 units
- Distribution
- Nationwide Distribution -- AR, AZ, CA, FLA, IL, MI, MN, MO, MS, NJ, OH, OR, PA, UT and VA.
- Date initiated
- 2007-05-30
- Date posted
- 2010-04-05
- Date terminated
- 2010-12-28
- 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 GAMMA KNIFE PERFEXION (K063512) | Elekta Instrument AB | 2007-03-05 |