Leksell Vantage Stereotactic System. Instrument Carrier, Part of Leksell Vantage Arc (1053958). Neurological stereotaxic Instrument
Class I - DangerousWhat Should You Do?
- Check if you have this product: Serial Numbers:SH00106, SH00120, SH00149, SH00160, SH00165, SH00110, SH00143, SH00150, SH00161, SH00166, SH00111, SH00144, SH00157, SH00162, SH00167, SH00112, SH00147, SH00158, SH00163, SH00168, SH00114, SH00148, SH00159, SH00164 and SH00178. UDI 7340048304887.
- 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:
- A faulty locking piece of the Instrument Carrier that does not fulfil the requirement of locking force to the Arc has been found during an internal check of a Leksell Vantage Stereotactic Arc System.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Leksell Vantage Stereotactic System. Instrument Carrier, Part of Leksell Vantage Arc (1053958). Neurological stereotaxic Instrument
Product Codes/Lot Numbers:
Serial Numbers:SH00106, SH00120, SH00149, SH00160, SH00165, SH00110, SH00143, SH00150, SH00161, SH00166, SH00111, SH00144, SH00157, SH00162, SH00167, SH00112, SH00147, SH00158, SH00163, SH00168, SH00114, SH00148, SH00159, SH00164 and SH00178. UDI 7340048304887.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1826-2020
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