—#110554

Product

Monaco Product Usage: Planning of radiation therapy

FDA product code: MUJ — System, Planning, Radiation Therapy Treatment
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K110730
Affected lot / code info: Version 3.10.00 - 3.20.00, 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

Elekta sent an Important Safety Notice to affected customers. The notice identified the affected product, problem, clinical impact and actions to be taken. The notice inform customers of how the issue will be resolved and instructions to follow when it is available.

Recalling firm

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

Distribution

Distribution pattern: US Nationwide Distribution - including the states of: 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 #110554. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.