INFX-8000F Fluoroscopic X-Ray Systems

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Serial Numbers: AHA1592004, AGB1482001, AHA1482001, AGA1492002, AHA14Z2002, AGA1552003, UUB13Y2039, AHA15Y2005, AHA1612006, AHB1662007, AGB1682004, AGB1692005, AGB16Z2006, AHB1712008, AHB1712009, AGB1712007, AHA1582003
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. 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:
Toshiba American Medical Systems Inc
Reason for Recall:
During an examination a device error occurred and the ceiling drive operation was disabled. It was found that the fastening bolts of the driving portion of the ceiling drive loosened cause the error.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

INFX-8000F Fluoroscopic X-Ray Systems

Product Codes/Lot Numbers:

Serial Numbers: AHA1592004, AGB1482001, AHA1482001, AGA1492002, AHA14Z2002, AGA1552003, UUB13Y2039, AHA15Y2005, AHA1612006, AHB1662007, AGB1682004, AGB1692005, AGB16Z2006, AHB1712008, AHB1712009, AGB1712007, AHA1582003

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0842-2018

Related Recalls

The power supply unit may be damaged and may fail to start up when the power plug is inserted into a power outlet while the main power switch on the rear of the system is set to ON.

Jan 4, 2018 Diagnostic Equipment Nationwide View Details →

INFX-8000C Fluoroscopic X-Ray Systems

Toshiba American Medical Systems

Class I - Dangerous

During an examination a device error occurred and the ceiling drive operation was disabled. It was found that the fastening bolts of the driving portion of the ceiling drive loosened cause the error.

Dec 29, 2017 Other Medical Devices View Details →

INFX-8000H Fluoroscopic X-Ray Systems

Toshiba American Medical Systems

Class I - Dangerous

During an examination a device error occurred and the ceiling drive operation was disabled. It was found that the fastening bolts of the driving portion of the ceiling drive loosened cause the error.

Dec 29, 2017 Other Medical Devices View Details →