FDA-Device2017-12-20Class II
Elekta ERGO++ Product Usage: ERGO is often used for stereotactic treatments.
Elekta Inc
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.
Sold states
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, MALAYSIA, MEXICO, NETHERLANDS, NEW ZEALAND, PERU, PHILIPPINES, PORTUGAL, RUSSIA, SAUDI ARABIA, SINGAPORE, SOUTH KOREA, SPAIN, TAIWAN, THAILAND, TURKEY, VENEZUELA, and VIETNAM
Affected count
182
Manufactured in
13723 Riverport Dr Ste 100, N/A, Maryland Heights, MO, United States
Products
Elekta ERGO++ Product Usage: ERGO is often used for stereotactic treatments.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0234-2018Don't want to check this manually?
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