FDA Medical Device Recalls (openFDA)
Elekta, Inc.: Leksell Gamma Knife. Leksell Gamma Knife is a teletherapy device indicated for use in the stereotactic irradiation of intracranial structures
- Recall number
- Z-1236-2010
- Recalling firm
- Elekta, Inc.
- Product
- Leksell Gamma Knife. Leksell Gamma Knife is a teletherapy device indicated for use in the stereotactic irradiation of intracranial structures
- Status
- Terminated
- Initiated
- 2007-10-01
- Posted
- 2010-04-13
- Terminated
- 2010-12-28
- Reason
- 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.
- Root cause
- Other
- Action
- 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.
- Quantity
- 5 units
- Distribution
- United States (CA, TN, TX and WA) and Taiwan.
- Lot, serial or model codes
- LGK 4203, LGK 4309, LGK 4333, LGK 4343 and LGK 4354.
- 510(k) numbers
- ["K984328"]
- PMA numbers
- not on file
- Product code
- IWB
- Firm FEI
- 1037831
- Firm city
- Norcross
- Firm state
- GA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28