—#110552

Product

Focal SIM Planning of radiation therapy

FDA product code: MUJ — System, Planning, Radiation Therapy Treatment
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K013112
Affected lot / code info: Version 4.64.00 - 4.700, inclusive

Why it was recalled

Incorrect patient shift directions when the Setup reference dialog is printed out when the DICOM coordinates option is enabled for reports.

Root cause (FDA determination)

Software design

Action the firm took

IMPAC Medical Systems, Inc. sent an Important Safety Notice LINFFM0001/1.0 on June 21, 2012, to consignees on concerning a patch to the software. The Notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to not use the DICOM coordinates option for Reports when printing the Setup Reference Diaglog. Customers were instructed go to www.elekta.com, select the SupportPlus Login at the tope of the page, enter their portal, select Downloads/Updates to download the latest patches. For questions regarding this recall call 770-670-2548.

Recalling firm

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

Distribution

Distribution pattern: Nationwide Distribution including CA, CT, FL, IL, IN, KY, MI, MN, MO, NJ, NY, NC, OH, OK, OR, PA, WA, and WI.

Timeline

Recall initiated: 2012-06-21
Posted by FDA: 2012-07-12
Terminated: 2014-04-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #110552. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.