Elekta, Inc.: Elekta Synergy XVI Intended use: Radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner.

Recall number

Z-1252-2011

Recalling firm

Elekta, Inc.

Product

Elekta Synergy XVI Intended use: Radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner.

Status

Terminated

Initiated

2011-01-05

Posted

2011-02-15

Terminated

2011-04-07

Reason

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.

Root cause

Other

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.

Quantity

223 units

Distribution

Nationwide distribution.

Lot, serial or model codes

105257, 105803, 105941, 105982, 105984, 151024, 151038, 151051, 151053, 151055, 151073, 151074, 151084, 151110, 151130, 151141, 151151, 151156, 151157, 151160, 151168, 151173, 151178, 151216, 151245, 151250, 151256, 151258, 151259, 151260, 151298, 151301, 151309, 151317, 151319, 151326, 151327, 151328, 151340, 151352, 151359, 151360, 151362, 151363, 151371, 151387, 151391, 151394, 151396, 151398, 151410, 151411, 151412, 151416, 151418, 151423, 151432, 151433, 151435, 151441, 151443, 151446, 151467, 151479, 151504, 151507, 151514, 151515, 151517, 151519, 151521, 151522, 151523, 151530, 151538, 151540, 151545, 151557, 151558, 151566, 151567, 151568, 151574, 151584, 151585, 151587, 151595, 151598, 151601, 151611, 151616, 151623, 151626, 151627, 151628, 151632, 151634, 151636, 151640, 151653, 151664, 151672, 151674, 151675, 151678, 151683, 151684, 151689, 151694, 151695, 151696, 151698, 151699, 151700, 151704, 151705, 151708, 151710, 151714, 151722, 151724, 151728, 151729, 151734, 151736, 151751, 151759, 151760, 151763, 151764, 151765, 151770, 151774, 151779, 151782, 151783, 151785, 151789, 151791, 151793, 151801, 151802, 151803, 151805, 151808, 151809, 151810, 151811, 151812, 151820, 151828, 151839, 151842, 151847, 151848, 151855, 151860, 151864, 151866, 151867, 151875, 151881, 151882, 151885, 151886, 151892, 151931, 151933, 151942, 151952, 151953, 151955, 151956, 151958, 151959, 151960, 151961, 151965, 151969, 151977, 151978, 151981, 151989, 152008, 152019, 152023, 152031, 152043, 152051, 152064, 152079, 152080, 152091, 152098, 152103, 152115, 152116, 152117, 152123, 152126, 152154, 152158, 152163, 152174, 152175, 152176, 152177, 152192, 152200, 152210, 152211, 152214, 152217, 152220, 152222, 152223, 152232, 152246, 152257, 152271, 152301, 152307, 152308

510(k) numbers

["K051932"]

PMA numbers

not on file

Product code

IYE

Firm FEI

1037831

Firm city

Norcross

Firm state

GA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

Copy