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

FDA device recall Z-1705-2016 · posted 2016-05-23 · Terminated

Recall details

Recalling firm

Elekta, Inc.

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.

Action taken

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

Status

Terminated

Product code

IYE

Quantity affected

20

Distribution

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

Date initiated

2016-05-12

Date posted

2016-05-23

Date terminated

2021-07-16

Location

Atlanta, GA

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