—#104476

Product

Elekta Leksell Gamma Plan Product Usage: Gamma Plan is a computer based system designed for Gamma Knife treatment planning.

FDA product code: IWB — System, Radiation Therapy, Radionuclide
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K973441
Affected lot / code info: 6107 and 6115

Why it was recalled

There is a risk that the user may interpret the instructions in the manual too literally, and adjust the TMR 10 dose description to obtain an ETCPD that matches previous clinical prescriptions, which in turn could lead to a prescription dose that deviates a few percent from the intended dose.

Root cause (FDA determination)

Labeling False and Misleading

Action the firm took

Elekta sent an IMPORTANT NOTICE letter dated June 23, 2011 to affected customers. The notice identified the product, problem, and corrective actions to be taken by the user. The letter advise all customers to follow any instructions or recommendations covered in the Notice. The letter states that Elekta is working on a new software version and customers will receive the future version when released. For questions contact your local Elekta representative.

Recalling firm

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

Distribution

Distribution pattern: Nationwide Distribution (USA) - including the states of: NM and WA

Timeline

Recall initiated: 2011-06-23
Posted by FDA: 2011-11-30
Terminated: 2012-01-31
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #104476. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.