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 radiati

FDA device recall Z-1555-2011 · posted 2011-03-04 · Terminated

Recall details

Recalling firm

Elekta, Inc.

Reason for recall

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.

Action taken

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.

Root cause

Other

Status

Terminated

Product code

IYE

Quantity affected

229 units

Distribution

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

Date initiated

2007-08-23

Date posted

2011-03-04

Date terminated

2011-04-07

Location

Norcross, GA

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