Leksell Gamma Knife Perfexion, Product Number: 715000. Radionuclide radiation therapy system. Elekta, Inc. Norcross, GA. Intended for stereotactic irradiation of head structures ranging from very small target sizes of a few millimeters to several centimeters.
This recall has been terminated (originally issued April 5, 2010).
- Company
- Elekta, Inc.
- Recall Initiated
- November 6, 2009
- Posted
- April 5, 2010
- Terminated
- December 14, 2010
- Recall Number
- Z-1232-2010
- Quantity
- 32 units
- Firm Location
- Norcross, GA
- Official Source
- View on FDA website ↗
Reason for Recall
There may be a situation where the Frame Adapter might lock the stereotactic Frame in the wrong position.
Distribution
Nationwide Distribution -- AZ, CA, FL, IL, KY, MI, MN, MS, MO, NY, NC, OH, OR, PA, SC, TX, UT and VA.
Lot / Code Info
Serial Numbers: 6004, 6006, 6008, 6009, 6010, 6011, 6012, 6014, 6015, 6016, 6020, 6021, 6022, 6023, 6025, 6029, 6030, 6032, 6034, 6035, 6036, 6037, 6045, 6047, 6048, 6049, 6053, 6054, 6056, 6057, 6059 and 6061.
Root Cause
Software design
Action Taken
Elekta, Inc. issued a Field Change Order 200 091 titled "Update Frame Adapter with New Frame Fixation Axle" dated November 6, 2009. Consignees were given instructions to prevent further issues related to the affected device. For further information, contact Elekta, Inc. at 1-770-300-9725.