Elekta, Inc. recalls Monaco RTP System; Used to make treatment plans for patients with prescriptions for external beam radiation therapy.

Recalled December 7, 2016 · FDA recall Z-0660-2017 · Elekta

Hazard

Incorrect Dose when using the reset function. · FDA Class II

Units

671

Sold at

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,

Description

Incorrect Dose when using the reset function.

Product

Monaco RTP System; Used to make treatment plans for patients with prescriptions for external beam radiation therapy.

Manufacturer(s)

Elekta, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →