ELEKTA Digital Accelerator under the following brand names: Elekta Synergy, Synergy S, Synergy Platform, Precise Digital Accelerator, Infinity, Axesse, and Versa HD
Reported: August 29, 2018 Initiated: December 1, 2017 #Z-2840-2018
Product Description
ELEKTA Digital Accelerator under the following brand names: Elekta Synergy, Synergy S, Synergy Platform, Precise Digital Accelerator, Infinity, Axesse, and Versa HD
Reason for Recall
There is a potential for an uncontrolled extension of iViewGT / XVI detector arms.
Details
- Recalling Firm
- Elekta, Inc.
- Units Affected
- 2,998
- Distribution
- 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
- Location
- Atlanta, GA
Frequently Asked Questions
What product was recalled? ▼
ELEKTA Digital Accelerator under the following brand names: Elekta Synergy, Synergy S, Synergy Platform, Precise Digital Accelerator, Infinity, Axesse, and Versa HD. Recalled by Elekta, Inc.. Units affected: 2,998.
Why was this product recalled? ▼
There is a potential for an uncontrolled extension of iViewGT / XVI detector arms.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 29, 2018. Severity: Moderate. Recall number: Z-2840-2018.
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