Leksell Gamma Knife Perfexion, Product Number: 715000. Radionuclide radiation therapy system. Elekta, Inc. Norcross, GA.
FDA device recall Z-1232-2010 · posted 2010-04-05 · Terminated
Recall details
- Recalling firm
- Elekta, Inc.
- Reason for recall
- There may be a situation where the Frame Adapter might lock the stereotactic Frame in the wrong position.
- Action taken
- Elekta, Inc. issued a Field Change Order 200 091 titled "Update Frame Adapter with New Frame Fixation Axle" dated November 6, 2009. Consignees were given instructions to prevent further issues related to the affected device. For further information, contact Elekta, Inc. at 1-770-300-9725.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IWB
- Quantity affected
- 32 units
- Distribution
- Nationwide Distribution -- AZ, CA, FL, IL, KY, MI, MN, MS, MO, NY, NC, OH, OR, PA, SC, TX, UT and VA.
- Date initiated
- 2009-11-06
- Date posted
- 2010-04-05
- 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 GAMMA KNIFE PERFEXION (K063512) | Elekta Instrument AB | 2007-03-05 |