Leksell Gamma Knife Perfexion. Radionuclide radiation therapy system. Elekta, Inc. Norcross, GA. Indicated for use in the stereotactic irradiation of intracranial structures.
This recall has been terminated (originally issued April 5, 2010).
- Company
- Elekta, Inc.
- Recall Initiated
- May 30, 2007
- Posted
- April 5, 2010
- Terminated
- December 28, 2010
- Recall Number
- Z-1231-2010
- Quantity
- 18 units
- Firm Location
- Norcross, GA
- Official Source
- View on FDA website ↗
Reason for Recall
There has been an issue with "Image Fushing" where low precision calculation caused images to become inaccurate.
Distribution
Nationwide Distribution -- AR, AZ, CA, FLA, IL, MI, MN, MO, MS, NJ, OH, OR, PA, UT and VA.
Lot / Code Info
Serial Numbers: 6004-6006, 6009-6012, 6014-6018, 6020-6023, 6025, 6027 and 6029-6032.
Root Cause
Software design
Action Taken
Elekta, Inc. issued a Field Change Order, Reference Number 0000946 dated March 14, 2008. Consignees were informed of the affected product and instructed on necessary steps to take. For further information, contact Elekta, Inc. at 1-770-300-9725.
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