🔍 RecallPedia

OmniTom Computed tomography x-ray system, Model NL5000, all NL5000 systems with software version before 05.01.01 - Product Usage: is intended to be used for x-ray computed tomography applications for anatomy that can be imaged in the 40 cm aperture, primarily head and neck.

Class I - Dangerous
🏥 Medical Devices Recalled: July 15, 2020 NeuroLogica Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    UDI: 08806167789220; all NL5000 systems with software version before 05.01.01; Serial Numbers: 00008 00009 00010 00011 00012 00013 00016 00018 00020 00021 00022 00023 00024 00027 00030 00031 00032 00033 00035 00036 00037 00040 00043 00044 00045 00046 00007 00014 00017 00028 00034 00038 00039 00041 00042
  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:
NeuroLogica Corporation
Reason for Recall:
There are potential issues related to the operational state of the scanner, specifically for transport and inadvertent system shutdowns. There could be a possibility of potential delay in patient treatment if proper use instructions are not followed.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

OmniTom Computed tomography x-ray system, Model NL5000, all NL5000 systems with software version before 05.01.01 - Product Usage: is intended to be used for x-ray computed tomography applications for anatomy that can be imaged in the 40 cm aperture, primarily head and neck.

Product Codes/Lot Numbers:

UDI: 08806167789220; all NL5000 systems with software version before 05.01.01; Serial Numbers: 00008 00009 00010 00011 00012 00013 00016 00018 00020 00021 00022 00023 00024 00027 00030 00031 00032 00033 00035 00036 00037 00040 00043 00044 00045 00046 00007 00014 00017 00028 00034 00038 00039 00041 00042

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2772-2020

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