Elekta Synergy XVI Intended use: Radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner.
FDA Recall Z-1252-2011 · Posted 2011-02-15
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Recalling FirmElekta, Inc.
Recall StatusTerminated
Product CodeIYE
Date Initiated2011-01-05
Date Terminated2011-04-07
Product Quantity223 units
Reason for Recall
Flexmap calibration did not cover the full 360 degrees of gantry rotation (0 to 355 degrees) and that this caused an isocenter displacement with 2D PlanarView images required at 180 to -180.
Firm Action
The firm, Elekta Limited, sent an "Important Notice A344" dated January 5, 2011 to all consignees/customers. The notice described the product, problem and action to be taken by the customers. The customers were instructed to follow any instructions or recommendations covered in the notice. The notice provides suggestions on how to check and prevent this situation from occurring; it instructs the User to file the document in the Important Notice section of the appropriate User Manual; to complete a FlexMap Check each time they acquire a new FlexMap and amend their local procedures to include the FlexMap Check and complete and return the Important Notice Confirmation of Receipt via Fax to: Field Support Administration, Elekta Limited, Linac House, Fleming Way Crawley, West Sussex, RH10 9RR UK +44 (0)1293 654401.
If you have any questions, contact Elekta Limited at +44 (0)1293 654200 or www.elekta.com.
Root Cause
Other
Distribution Pattern
Nationwide distribution.
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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