Recalls / —

—#151015

Product

Monaco RTP 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 Builds 5.11 and 5.20

Why it was recalled

Incorrect Dose when using the reset function.

Root cause (FDA determination)

Software design

Action the firm took

Important Field Safety Notice 382-01-MON-006 was sent to all affected customers on 11/3/2016. The notice informs users of the specific product and version numbers affected by the issue, and any work around that can be used to avoid the issue. An acknowledgement form was included which is to be returned to Elekta.

Recalling firm

Firm

Elekta, Inc.

Address

400 Perimeter Center Ter NE, Ste 50, Atlanta, Georgia 30346-1227

Distribution

Distribution pattern

AK, AZ, CA, CO, FL, GA, IL, IN, MA, MI, MN, MO, NV, NH, NY, NC, OH, OK, OR, PA, SD, TX, UT, VA, WA, WI, Algeria, Australia, Austria, Brazil, Canada, China, Cuba, Cyprus, Czech Republic, Ecuador, Egypt, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Laos, Malaysia, Mexico, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Norway, Peru, Poland, Portugal, Russia, Serbia, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, United Kingdom, Venezuela,

Timeline

Recall initiated

2016-11-03

Terminated

2021-07-16

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #151015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.