—#160084

Product

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

FDA product code: MUJ — System, Planning, Radiation Therapy Treatment
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K080601
Affected lot / code info: Version 1.7.3 and higher

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.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

Elekta sent an Urgent Important Field Safety Notification letter dated September, 2017. The letter identified affected product, problem and actions to be taken. Customers were instructed that a copy of the Important Field Safety Notice is to be kept with the most current labeling and all personnel working with the product should be made aware of the content of the letter. The customers were asked to complete the verification tests and return the Important Field Safety Notice Acknowledgment form to their local Elekta representative as soon as possible but no later than 30 days from receipt. For questions contact your local Elekta Care Support Center.

Recalling firm

Firm: Elekta Inc
Address: 13723 Riverport Dr, Ste 100, Maryland Heights, Missouri 63043-4819

Distribution

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

Timeline

Recall initiated: 2017-09-01
Terminated: 2019-11-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #160084. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.