Getinge 86 Series Washer/Disinfector with G1 control system software, Model 8666 and Model 8668. For use in healthcare facilities and laboratories where reusable items such as instruments, utensils, anesthesia sets, and glassware are handled for decontamination purposes.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Software versions up to and including 1.5.1.
- 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:
- Getinge Disinfection Ab
- Reason for Recall:
- Getinge Disinfection AB has initiated a Field Correction due to the potential for unauthenticated remote access to the product over the network.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Getinge 86 Series Washer/Disinfector with G1 control system software, Model 8666 and Model 8668. For use in healthcare facilities and laboratories where reusable items such as instruments, utensils, anesthesia sets, and glassware are handled for decontamination purposes.
Product Codes/Lot Numbers:
Software versions up to and including 1.5.1.
Distribution:
Distributed in: CA, CT, GA, IA, ID, MD, MI, MN, NY, PA, TX, WA
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2419-2015
Related Recalls
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Potential for device to overheat during operation f the circulation pressure calibration was not performed or had been performed incorrectly, and the low-pressure alarm is not triggered.
Washer Disinfector Aquadis 56; Model Number: 56M
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The frequency inverter is not programmed by supplier according to specification which causes the circulation pump to start earlier than expected, resulting in additional wear and tear, earlier than expected, on the axial seal in the pump housing.
Washer Disinfector Aquadis 56; Model Number: 56A
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The frequency inverter is not programmed by supplier according to specification which causes the circulation pump to start earlier than expected, resulting in additional wear and tear, earlier than expected, on the axial seal in the pump housing.