Elekta Synergy XVI Medical Linear Accelerator. Model Numbers R3.5, R4.0 and R4.2. Elekta, Inc. Norcross, GA 30092. Intended for use as a radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner.
FDA Recall Z-1405-2010 · Posted 2010-04-16
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Recalling FirmElekta, Inc.
Recall StatusTerminated
Product CodeIYE
Date Initiated2008-12-12
Date Terminated2010-12-28
Product Quantity76 units
Reason for Recall
It is possible that two (or more) CT reference data sets are necessary for one patient, for example, if you have to scan a patient during breath hold and then again during free breathing.
Firm Action
Elekta, Inc. issued an "Important Notice" dated December 12, 2008. Customers were informed of the affected device and instructed on proper steps until an update is provided.
For further information, contact Elekta, Inc. at 1-770-300-9725.
Root Cause
Software design
Distribution Pattern
Nationwide Distribution -- AL, AZ, CO, CT, FL, GA, ID, KS, KY, MA, MI, MN, MS, NE, NY, OH, OK, OR, PA, TN, TX, VA, WA and WV.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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