IGuide System, software versions: 2.2.0, 2.2.1, 2.2.2 Product Usage: Linear Accelerator. The intended use of the device is the control of accurate patient positioning with assistance of a 30 Tracking System in a radiotherapy environment.
FDA Recall Z-2082-2019 · Posted None
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Recalling FirmMedical Intelligence Medizintechnik Gmbh
Recall StatusTerminated
Product CodeIYE
Date Initiated2019-07-18
Date Terminated2023-08-11
Product Quantity496 units
Reason for Recall
Sometimes, although the HexaPOD has reached the target position, the Constant Correlation Check (CCC) can be too sensitive and iGUIDE may incorrectly demand a verification scan.
Firm Action
The firm sent an Urgent Important Field Safety Notification letter dated July 2019 via email. The identified the affected product, problem and actions to be taken. Customers were instructed to post this notice in a place accessible to all users, e.g. Instructions for Use, until this action is closed and advise the appropriate personnel, working with this product, on the content of this letter.
Root Cause
Software design
Distribution Pattern
Worldwide Distribution - US Nationwide
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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