Recalls / —
—#152501
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 - V 5.10.00 (including 5.10.01, 5.10.02); V 5.11.00 (including 5.11.01); V 5.20.00
Why it was recalled
Incorrect dose after editing beam number an wedge angle.
Root cause (FDA determination)
Other
Action the firm took
Elekta sent Important Field Safety Notice 382-01-MON-009 to all affected customers on 1/10/2017. The notice informs users of the specific product and version numbers by the issue, and any work arounds that can be used to avoid the issue. The notice informs customers that Elekta Regional Support Staff will contact them directly. The notice also included an acknowledgment form to be returned.
Recalling firm
- Firm
- Elekta, Inc.
- Address
- 400 Perimeter Center Ter NE, Ste 50, Atlanta, Georgia 30346-1227
Distribution
- Distribution pattern
- AZ, AR, CA, CO, CL, GA. IL, IN, LA, MA, MI, MN, MO, NV, NH, NJ, NY, NC, OH, OR, PA, SD, TX, UT, VA, WA, WI, Puerto Rico, Algeria, Antiqua & Barbuda, Argentina, Australia, Austria, Bangladesh, Bahrain, Belarus, Botswana, Brazil, Bulgaria, Canada, Chile, China, Columbia, Croatia, Cuba, Cyprus, Czech Republic, Ecuador, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Israel, Italy, Japan, Laos, Lithuania, Malaysia, Malta, Mexico, Morocco, Myanmar, Napal, Namibia, Netherlands, New Zealand, Norway, Panama, Philippines, Poland, Portugal, Peru, Romania, Russia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Switzerland, Thailand, Tunisia, Turkey, Ukraine, United Kingdom, Venezuela, Vietnam, Zimbabwe
Timeline
- Recall initiated
- 2017-01-10
- Terminated
- 2020-08-18
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #152501. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.