Elekta, Inc.: Desktop Pro 4.2, 5.0, 5.1, 6.0, 6.2 A user interface of rthe SL/SLi Series Linear Accelerators that are used for radiation therapy treatments of malignant neoplastic diseases, as determined by a licensed medical practitioner.

Recall number

Z-1555-2011

Recalling firm

Elekta, Inc.

Product

Desktop Pro 4.2, 5.0, 5.1, 6.0, 6.2 A user interface of rthe SL/SLi Series Linear Accelerators that are used for radiation therapy treatments of malignant neoplastic diseases, as determined by a licensed medical practitioner.

Status

Terminated

Initiated

2007-08-23

Posted

2011-03-04

Terminated

2011-04-07

Reason

Under certain conditions it has been found that movement of the collimators can be induced during multi segment beams such as IMRT and Omniwedge which will not be detected by the Desktop Pro if high values are sent within the iCom tolerance table.

Root cause

Other

Action

The firm, Elekta, sent an "Important Notice A302" dated August 23, 2007 titled "Update to iCom Tables for Desktop Pro when used with Third Party R&V Systems",to all affected customers. On September 28, 2007, Elekta issued a second Important Notice A304 which reiterated the same information as was in Important Notice A302. The notices described the product, problem and actions to be taken. This notice provides a workaround on how to avoid the issue. In order to avoid this issues documented, Elekta recommended that the customers set the tolerance for collimators in the iCom tolerance table to be 3.0 degrees-no less than 3.0 and to use the Linac Record, if configured, as a means of checking the final collimator position. Elekta noted that the issue will be resolved in a future release of Desktop Pro. If you any questions related to this issue, please contact your local Elekta, third party R&V system representative or Elekta Limited at +44 (0)1293 654200.

Quantity

229 units

Distribution

Worldwide distribution: USA including Puerto Rico and countries including: Canada and Mexico.

Lot, serial or model codes

134615, 134621, 134091, 136364, 134172, 136285, 134605, 134183, 136167, 136234, 134259, 134115, 134081, 136047, 136063, 134701, 134328, 134391, 134432, 134436, 134438, 136119, 134535, 134561, 134475, 134564, 134154, 134269, 134348, 134399, 136084, 136087, 136100, 134200, 134118, 134822, 134018, 136368, 134241, 134606, 134711, 134473, 134787, 134768, 134571, 134237, 134104, 136009, 134331, 134272, 136322, 136175, 136200, 134503, 136257, 134322, 134781, 134380, 134709, 136108, 134250, 134254, 134258, 134206, 134195, 134094, 134652, 134704, 136107, 134469, 134472, 134483, 134519, 134729, 136109, 134236, 134239, 134197, 134456, 134047, 134092, 134211, 136373, 134275, 134679, 136106, 136163, 134667, 136181, 134169, 134329, 134126, 134090, 134358, 134427, 134626, 134819, 134027, 134265, 134597, 136319, 134220, 134256, 134396, 134804, 134235, 136338, 134137, 134234, 134249, 136034, 136065, 136110, 136267, 136291, 134213, 134219, 136330, 134750, 136097, 136270, 134457, 134078, 134129, 136195, 134375, 134603, 136074, 134075, 134565, 134196, 134428, 134430, 134008, 134382, 134070, 134157, 134772, 136080, 134860, 134401, 134368, 134388, 134631, 134318, 136015, 136096, 134563, 136165, 136240, 134441, 134017, 134048, 134189, 134395, 134324, 134595, 134140, 134212, 136086, 134354, 136178, 136317, 136318, 134445, 136012, 136332, 134321, 136071, 136089, 136292, 136293, 134673, 134685, 136059, 136169, 134073, 134748, 134754, 134378, 134383, 134458, 134192, 134499, 136069, 136092, 134642, 134295, 134671, 136046, 136147, 134062, 136049, 136036, 136152, 136157, 136083, 136081, 134770, 136118, 136156, 136172, 134352, 134548, 134533, 136153, 136269, 136197, 136252, 136286, 136315, 136241, 134811, 134812, 136258, 136312, 134069, 136310, 134864, 134040, 134046, 134307

510(k) numbers

["K982713"]

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

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