Elekta ERGO++ Product Usage: ERGO is often used for stereotactic treatments.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Version 1.7.3 and higher
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Elekta Inc
- Reason for Recall:
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Elekta ERGO++ Product Usage: ERGO is often used for stereotactic treatments.
Product Codes/Lot Numbers:
Version 1.7.3 and higher
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0234-2018
Related Recalls
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Software may fail to load adapted baseline shift plan during treatment delivery when a communication error occurs.
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Locking mechanisms may not properly secure to the Arc system, resulting in shifting of coordinates during procedures.
Due to adapter not being properly aligned or locked in place.