ELEKTA Digital Accelerator under the following brand recall
ELEKTA Digital Accelerator under the following brand names: Elekta Synergy, Synergy S, Synergy Platform, Precise Digital Accelerator, Infinity…
Why was ELEKTA Digital Accelerator under the following brand recalled?
There is a potential for an uncontrolled extension of iViewGT / XVI detector arms.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All Digital Accelerators with XVI or iViewGT
- Product
- ELEKTA Digital Accelerator under the following brand names: Elekta Synergy, Synergy S, Synergy Platform, Precise Digital Accelerator, Infinity…
- Recalling firm
- Elekta, Inc.
- Quantity
- 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
- Recall date
- August 29, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)