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FDASeptember 1, 2017device

Elekta ERGO++ Product Usage: ERGO is often used for stereotactic treatments.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Incorrect DICOM mapping of the exported collimator or couch angles from ERGO, which would lead to incorrect rotation of the collimator or couch when using a MLC device for planning.

What to do

FDA enforcement status: Terminated

Brands named

elekta

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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Elekta ERGO++ Product Usage: ERGO is often used for stereotactic treatments. — Recall Details · AllClear