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Recall Observatory FDA recall evidence

Device product

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

Z-0234-2018

September 01, 2017

Class II

Product summary

Firm
Elekta Inc
Event
Event 78665
Status
Terminated
Classification
Class II
Quantity
182
Official record key
device-enforcement:Z-0234-2018

Official wording

Reason: 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.

Code information: Version 1.7.3 and higher

Distribution pattern: 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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.