—#89377

Product

Leksell Gamma Knife Perfexion. Radionuclide radiation therapy system. Elekta, Inc. Norcross, GA. Indicated for use in the stereotactic irradiation of intracranial structures.

FDA product code: IWB — System, Radiation Therapy, Radionuclide
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K063512
Affected lot / code info: Serial Numbers: 6004-6006, 6009-6012, 6014-6018, 6020-6023, 6025, 6027 and 6029-6032.

Why it was recalled

There has been an issue with "Image Fushing" where low precision calculation caused images to become inaccurate.

Root cause (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm: Elekta, Inc.
Address: 4775 Peachtree Industrial Blvd, Bldg 300 # 300, Norcross, Georgia 30092-3011

Distribution

Distribution pattern: Nationwide Distribution -- AR, AZ, CA, FLA, IL, MI, MN, MO, MS, NJ, OH, OR, PA, UT and VA.

Timeline

Recall initiated: 2007-05-30
Posted by FDA: 2010-04-05
Terminated: 2010-12-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #89377. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.