Incisive CT- whole-body computed tomography (CT) X-Ray System Model Number: 728144

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    UDI-Di: (01)00884838105508(21) Serial Numbers: 34053, 34092, 34164, 34168, 34179, 34195, 34200 (US) OUS: System Serial Number 34010 34020 34061 34070 34107 34108 34127 34142 34147 34157 34158 34161 34166 34176 34177 34178 34180 34194 34202 500453 500499 500501 500504 500506 500508 500511 500518 500529 550004 550023 550025 550034 550041 550052 550065 550069 550077 550079 550084 550086 550093 550103 550107 550114 550115 550119 550121 550128 550130 550140 550141 550150 550162 550164 550169 550174 550176 550181 550187 550188 550191 550194 550195 550203 550212 550234 550241 550248 550249 550251 550256 550266 550270 552038 552040 554023
  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 HEADQUARTERS CAMBRIDGE
Reason for Recall:
Potential for Incorrect Image Orientation resulting images may be flipped or reversed result in misdiagnosis, incorrect treatment of a condition, or additional radiation exposure if a rescan is required
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

Incisive CT- whole-body computed tomography (CT) X-Ray System Model Number: 728144

Product Codes/Lot Numbers:

UDI-Di: (01)00884838105508(21) Serial Numbers: 34053, 34092, 34164, 34168, 34179, 34195, 34200 (US) OUS: System Serial Number 34010 34020 34061 34070 34107 34108 34127 34142 34147 34157 34158 34161 34166 34176 34177 34178 34180 34194 34202 500453 500499 500501 500504 500506 500508 500511 500518 500529 550004 550023 550025 550034 550041 550052 550065 550069 550077 550079 550084 550086 550093 550103 550107 550114 550115 550119 550121 550128 550130 550140 550141 550150 550162 550164 550169 550174 550176 550181 550187 550188 550191 550194 550195 550203 550212 550234 550241 550248 550249 550251 550256 550266 550270 552038 552040 554023

Distribution:

Distributed in: AR, CA, OK, TX

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1622-2023

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