Elekta ERGO++ Product Usage: ERGO is often used for recall
Elekta ERGO++ Product Usage: ERGO is often used for stereotactic treatments.
Why was Elekta ERGO++ Product Usage: ERGO is often used for 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Version 1.7.3 and higher
- Product
- Elekta ERGO++ Product Usage: ERGO is often used for stereotactic treatments.
- Recalling firm
- Elekta Inc
- 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, JORDAN, MALAYSIA, MEXICO, NETHERLANDS, NEW ZEALAND, PERU, PHILIPPINES, PORTUGAL, RUSSIA, SAUDI ARABIA, SINGAPORE, SOUTH KOREA, SPAIN, TAIWAN, THAILAND, TURKEY, VENEZUELA, and VIETNAM
- Recall date
- December 20, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)