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

Recall date

September 1, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0234-2018

FDA classification

Class II

Brand / firm

Elekta Inc

Sold / distributed

Worldwide Distribution - US Nationwide in the states of: VA, CA, TX, MO, NY, WA, NM, MA, FL, CT, OK, SC, MS, NY, GA, NC and the countries of: AUSTRALIA, BANGLADESH, BRAZIL, BULGARIA, CANADA, COLOMBIA, CZECH REPUBLIC, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDIA, IRELAND, ITALY, JAPAN, JORDAN,…

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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