Leksell Gamma Knife Perfexion, Article #715000. Teletherapy device intended for stereotactic irradiation of head structu
FDA device recall Z-1158-2010 · posted 2010-03-17 · Terminated
Recall details
- Recalling firm
- Elekta, Inc.
- Reason for recall
- Need to modify the closing speed of the shielding doors in the event of an emergency exit
- Action taken
- A field action (FCO TN-07-0007) has been performed to modify the shielding door speed on all sites in clinical use. A second Field Change Order 200 069 "Replacement of Door Servo Board" dated 9/16/08 was released.
- Root cause
- Other
- Status
- Terminated
- Product code
- IWB
- Quantity affected
- 19
- Distribution
- Worldwide Distribution -- USA, including states of AR, AZ, CA, FL, IL, MI, MN, MS, NJ, OH, OR, PA, UT, VA and countries of France and United Kingdom.
- Date initiated
- 2007-07-02
- Date posted
- 2010-03-17
- Date terminated
- 2010-03-25
- 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 |