Recall Z-0234-2018 ยท MUJ System, Planning, Radiation Therapy Treatment
Elekta Inc
Elekta ERGO++ Product Usage: ERGO is often used for stereotactic treatments.
| Date | Sep 1, 2017 |
| Status | Terminated |
| 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. |
| Root cause | Nonconforming Material/Component |
| Action | 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. |
| Quantity | 182 |
| Distribution | 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, JORDA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K080601 | ERGO++ VERSION 1.7 3D Line Medical Systems S.R.L., Jun 6, 2008 |