Home / Recalls / Elekta, Inc. / Z-1044-2017

Z-1044-2017 Class II Terminated

Recalled by Elekta, Inc. — Atlanta, GA

Recall Details

Product Type
Devices
Report Date
January 25, 2017
Initiation Date
January 10, 2017
Termination Date
August 18, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1999

Product Description

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

Reason for Recall

Incorrect dose after editing beam number an wedge angle.

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

Code Information

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

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