—#89782

Product

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.

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, 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.

Why it was recalled

There may be a situation where the Frame Adapter might lock the stereotactic Frame in the wrong position.

Root cause (FDA determination)

Software design

Action the firm took

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.

Recalling firm

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

Distribution

Distribution pattern: Nationwide Distribution -- AZ, CA, FL, IL, KY, MI, MN, MS, MO, NY, NC, OH, OR, PA, SC, TX, UT and VA.

Timeline

Recall initiated: 2009-11-06
Posted by FDA: 2010-04-05
Terminated: 2010-12-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #89782. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.