Leksell Gamma Knife. Leksell Gamma Knife is a teletherapy device indicated for use in the stereotactic irradiation of intracranial structures
This recall has been terminated (originally issued April 13, 2010).
- Company
- Elekta, Inc.
- Recall Initiated
- October 1, 2007
- Posted
- April 13, 2010
- Terminated
- December 28, 2010
- Recall Number
- Z-1236-2010
- Quantity
- 5 units
- Firm Location
- Norcross, GA
- Official Source
- View on FDA website ↗
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.
Distribution
United States (CA, TN, TX and WA) and Taiwan.
Lot / Code Info
LGK 4203, LGK 4309, LGK 4333, LGK 4343 and LGK 4354.
Root Cause
Other
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.
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