Leksell Gamma Knife. Leksell Gamma Knife is a teletherapy device indicated for use in the stereotactic irradiation of in
FDA device recall Z-1236-2010 · posted 2010-04-13 · Terminated
Recall details
- Recalling firm
- Elekta, Inc.
- Reason for recall
- After updating the LGK actuator in spare part 810361, the old sleigh became obsolete due to causing insufficient locking of the helmet in combination with the new actuator.
- Action taken
- Field Change Order 0000203 "Replacement of obsolete actuator sleigh on Helmet Changer", was sent to all customers that were affected. Direct questions to Elekta, Inc. by calling 1-770-670-2548.
- Root cause
- Other
- Status
- Terminated
- Product code
- IWB
- Quantity affected
- 5 units
- Distribution
- United States (CA, TN, TX and WA) and Taiwan.
- Date initiated
- 2007-10-01
- Date posted
- 2010-04-13
- 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 TARGET SYSTEM, MODEL 24001 (K984328) | Elekta Instrument AB | 1999-05-21 |