Brilliance iCT Computed Tomography X-ray system, Model 728306

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    85003, 85004, 85010, 85033, 85035, 85038, 85043, 85054, 85060, 100054, 100064, 100093, 100113, 100119, 100134, 100180, 100181, 100185, 100280, 100304, 100318, 100328, 100356, 100368, 100466, 100600, 100606, 100611, 100629, 100630, 100631, 100632, 100633, 100634, 100635, 100638, 100643, 100645, 100648, 100649, 100652, 100653, 100654, 100655, 100658, 100663, 100665, 100673, 100674, 100680, 100684, 100685, 100688, 100690, 100693, 100695, 100698, 100699, 100700, 100701, 100702, 100703, 100704, 100708, 100720, 100743, 200005
  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:
Philips Medical Systems (Cleveland) Inc
Reason for Recall:
The product label does not include the correct current rating.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Brilliance iCT Computed Tomography X-ray system, Model 728306

Product Codes/Lot Numbers:

85003, 85004, 85010, 85033, 85035, 85038, 85043, 85054, 85060, 100054, 100064, 100093, 100113, 100119, 100134, 100180, 100181, 100185, 100280, 100304, 100318, 100328, 100356, 100368, 100466, 100600, 100606, 100611, 100629, 100630, 100631, 100632, 100633, 100634, 100635, 100638, 100643, 100645, 100648, 100649, 100652, 100653, 100654, 100655, 100658, 100663, 100665, 100673, 100674, 100680, 100684, 100685, 100688, 100690, 100693, 100695, 100698, 100699, 100700, 100701, 100702, 100703, 100704, 100708, 100720, 100743, 200005

Distribution:

Nationwide distribution

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0593-2017

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