OEC UroView 2800, fluoroscopic x-ray system

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    monitor part numbers: 5448359-01, 5459219-01, or 5475662-03:89-3853, 82-1593, 8S-1935, 89-3356, 89-1323, 8S-2885, 82-0700, 8S-1708, 82-0420, 82-1998, 8S-2027, 82-7101-MH, 8S-2670, P6-0375-L, 8S-1614, 89-0846, 82-0576, 82-3256, 8S-2202, 89-0711,89-1927, 89-1453, 82-1504, 82-0794, 82-3494, 8S-3125, 8S-1845-RC, 89-3725, 8S-1592, 89-3129,82-1182, 82-0986, 8S-0199, 8S-3613, 82-3748, 82-2335, 8S-2889, 82-0596, 89-3020, 82-1515, 8S-0645, 8S-3614, 82-3925, 89-0416, 89-1363, 82-3258, 8S-0347
  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:
GE OEC Medical Systems, Inc
Reason for Recall:
A firmware issue in the supplied LCD workstation monitor(s). Under some circumstances, the monitor(s) may appear dark with no video displayed.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

OEC UroView 2800, fluoroscopic x-ray system

Product Codes/Lot Numbers:

monitor part numbers: 5448359-01, 5459219-01, or 5475662-03:89-3853, 82-1593, 8S-1935, 89-3356, 89-1323, 8S-2885, 82-0700, 8S-1708, 82-0420, 82-1998, 8S-2027, 82-7101-MH, 8S-2670, P6-0375-L, 8S-1614, 89-0846, 82-0576, 82-3256, 8S-2202, 89-0711,89-1927, 89-1453, 82-1504, 82-0794, 82-3494, 8S-3125, 8S-1845-RC, 89-3725, 8S-1592, 89-3129,82-1182, 82-0986, 8S-0199, 8S-3613, 82-3748, 82-2335, 8S-2889, 82-0596, 89-3020, 82-1515, 8S-0645, 8S-3614, 82-3925, 89-0416, 89-1363, 82-3258, 8S-0347

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2628-2016

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