FDAClass IIFebruary 26, 2014

Synergy XVI XVI can incorrectly calculate the target recall

Synergy XVI XVI can incorrectly calculate the target position of the treatment table, because of an error that does not occur very frequently. This is…

Why was Synergy XVI XVI can incorrectly calculate the target recalled?

XVI can incorrectly calculate the target position of the treatment table.

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?

Model 4.5, 4.5.1, 4.6, 5.0

Product
Synergy XVI XVI can incorrectly calculate the target position of the treatment table, because of an error that does not occur very frequently. This is…
Recalling firm
Elekta, Inc.
Quantity
1028
Distribution
Worldwide Distribution - USA (nationwide) including Puerto Rico and the states of AL, AK, AZ, AR, CA, CT, FL, GA, ID, IL, KY, LA, MD, MA, MI, MN, MO, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SD, TN, TX, VT, VA, WA, WV, WI, WY and DC., and the countries of Algeria, Australia, Austria, Bahrain, Belarus, Belgium, Brazil, Bulgaria, Canada, China, Columbia, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Ecuador, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Iraq, Ireland, Israel, Italy, Japan, Jordan, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Pakistan, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom and Venezuela
Recall date
February 26, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
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