Reported Dec 20, 2017 · Terminated
Elekta ERGO++ Product Usage: ERGO is often used for stereotactic treatments.
Elekta Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Elekta Inc · 13723 Riverport Dr Ste 100 · Maryland Heights, MO · 63043-4819
Is this the product you have?
- Elekta ERGO++
- Product UsageERGO is often used for stereotactic treatments
- Lot codes and dates
- Version 1.7.3 and higher
- Amount recalled
- 182
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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