Leksell Gamma Knife Perfexion, Radionuclide radiation therapy system. Article Number 715000, Elekta, Inc. Norcross, GA 3
FDA device recall Z-1230-2010 · posted 2010-04-05 · Terminated
Recall details
- Recalling firm
- Elekta, Inc.
- Reason for recall
- Radiation unit doors could close too fast on emergency exit.
- Action taken
- Field Change Order 200 070 "MCU CS SW 8.3" dated September 11, 2008 was released. Consignees were informed of the necessary steps to avoid further issues relating to the affected product. For further information, contact Elekta, Inc. at 1-770-300-9725.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IWB
- Quantity affected
- 19 units
- Distribution
- Nationwide Distribution -- AR, AZ, CA, FL, IL, MI, MN, MS, MO, NJ, OH, OR, PA, UT and VA.
- Date initiated
- 2008-11-09
- 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 |