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Terminated

iGUIDE System, for patient positioning, with assistance of a 30 Tracking System in a radiotherapy environment.

FDA Recall Z-1705-2016 · Posted 2016-05-23

Recalling FirmElekta, Inc.
Recall StatusTerminated
Product CodeIYE
Date Initiated2016-05-12
Date Terminated2021-07-16
Product Quantity20

Reason for Recall

If by mistake the initial pre-treatment imaging was performed BEFORE the HexaPOD was moved to the DRIVE (*START) position, iGUIDE offers the possibility to branch into a specific catch-up workflow, which was implemented to use the initial scan data.

Firm Action

Elekta sent an Important Field Safety Notice that was distributed to all affected customers on May 12, 2016. The notice informs end users about the problem and the potential clinical impact. It also gives a recommendation how the risk can be mitigated. The notice also advises the customer that a patch will be released that will introduce a patch that avoids an inaccurate position and thus eliminates an unsafe situation. Corrective Action #2: Permanent Solution Software Upgrade A software patch will be released that will correct the behavior of the iGUIDE software. The target release date for this patch is January 2017. Service teams will have 6 months from the date of release to correct all affected devices in the field. For further questions, call (770) 300-9725.

Root Cause

Software design

Distribution Pattern

IL, LA, Austria, Australia, Botswana, Germany, Denmark, France, India, Japan

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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