Z-2840-2018 Class II Terminated
FDA device recall Z-2840-2018 was initiated by Elekta, Inc. on December 1, 2017 and is designated Class II. Reason for recall: There is a potential for an uncontrolled extension of iViewGT / XVI detector arms. The recall status is terminated (terminated November 5, 2019). Affected quantity: 2,998.
Recall Details
- Product Type
- Devices
- Report Date
- August 29, 2018
- Initiation Date
- December 1, 2017
- Termination Date
- November 5, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,998
Product Description
Reason for Recall
Distribution Pattern
Worldwide Distribution - US Nationwide in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Alaska, District of Columbia, Hawaii and Puerto Rico Albania, Algeria Antigua and Barbuda Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Botswana, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Cuba, Curacao, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Gabon, Georgia, Germany, Ghana, Greece, Honduras, Hong Kong, Hungary, India, Indonesia, Iran (Islamic Republic of), Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of, Lao People's Democratic Republic, Libyan Arab Jamahiriya, Lithuania, Malaysia, Malta, Mexico, Morocco, Mozambique, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nigeria, Norway, Pakistan, Panama, Paraguay, Peru, Philippines, Portugal, Republic of Serbia, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Kingdom, Venezuela, Viet Nam and Zimbabwe