—#140260

Product

Monaco Radiation Treatment Planning System. Used to make treatment plans for patients with prescriptions for external beam radiation therapy.

FDA product code: MUJ — System, Planning, Radiation Therapy Treatment
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K151233
Affected lot / code info: Software Version 5.10.00

Why it was recalled

Dose and MU are incorrect when CT images are viewed from the head, and, when using multiple prescriptions with forced densities.

Root cause (FDA determination)

Device Design

Action the firm took

The firm issued an URGENT IMPORTANT FIELD SAFETY NOTICE on 09/15/2015. The letter identified the affected device, as well as the reason for the recall, and clinical impact. Customers were informed that both issues would be resolved in Monaco Patch Release 5.10.01. The attached acknowledgement form should be completed, signed, and returned to a local Elekta Office or representative within 30 days. Questions regarding the notice should be directed to a local Elekta office.

Recalling firm

Firm: Elekta, Inc.
Address: 400 Perimeter Center Ter NE, Ste 50, Atlanta, Georgia 30346-1227

Distribution

Distribution pattern: Worldwide Distribution -- US, including the states of CA, IN, MI, MO, TX and WI; and, the countries of Australia, Canada, Germany, Greece, India, Netherlands, New Zealand, Turkey, and the UK.

Timeline

Recall initiated: 2015-09-15
Posted by FDA: 2015-10-07
Terminated: 2017-04-04
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #140260. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.