FDA Recall
Terminated
Leksell Gamma Knife Perfexion, Radionuclide radiation therapy system. Article Number 715000, Elekta, Inc. Norcross, GA 30092. Teletherapy device intended for stereotactic irradiation of head structures ranging from very small target sized os a few millimeters to several centimeters.
Recall: Z-1230-2010
·
Initiated November 9, 2008
Recall
- Recall Number
- Z-1230-2010
- Event Number
- 54564
- Firm
- Elekta, Inc.
- FEI Number
- 1037831
- Product Code
- IWB
- Status
- Terminated
- Root Cause
- Software design
- Initiated
- November 9, 2008
- Posted
- April 5, 2010
- Terminated
- December 28, 2010
- Address
- 4775 Peachtree Industrial Blvd, Bldg 300 # 300, Norcross, GA, 30092-3011
Description
Leksell Gamma Knife Perfexion, Radionuclide radiation therapy system. Article Number 715000, Elekta, Inc. Norcross, GA 30092. Teletherapy device intended for stereotactic irradiation of head structures ranging from very small target sized os a few millimeters to several centimeters.
Reason
Radiation unit doors could close too fast on emergency exit.
Action
Field Change Order 200 070 "MCU CS SW 8.3" dated September 11, 2008 was released. Consignees were informed of the necessary steps to avoid further issues relating to the affected product. For further information, contact Elekta, Inc. at 1-770-300-9725.
Distribution
Nationwide Distribution -- AR, AZ, CA, FL, IL, MI, MN, MS, MO, NJ, OH, OR, PA, UT and VA.
Quantity
19 units