🔍 RecallPedia

Olympus, Model No. TJF-160F, flexible scope, large diameter, video duodenoscope

Class I - Dangerous
🏥 Medical Devices Recalled: January 20, 2016 Integrated Medical Systems Diagnostic Equipment Nationwide

What Should You Do?

  1. Check if you have this product:
    Serial Numbers: 2201503,2000062,2000105,2100621,2301997,2100999,2201555,2302025,2000061, 2201491,2000039,2100930,2402518,2302084,2100852,2101121
  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:
Integrated Medical Systems Inc
Reason for Recall:
If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Olympus, Model No. TJF-160F, flexible scope, large diameter, video duodenoscope

Product Codes/Lot Numbers:

Serial Numbers: 2201503,2000062,2000105,2100621,2301997,2100999,2201555,2302025,2000061, 2201491,2000039,2100930,2402518,2302084,2100852,2101121

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0905-2016

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