iDesign, Model - G300: System AWS (International), System AWS (China), Advanced WaveScan Studio (United States); iDesign Refractive Studio Aberrometer (International) and (United States), Model: G301

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    G300 with Windows XP. G301 with Windows 7 Embedded System.
  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:
AMO Manufacturing USA, LLC
Reason for Recall:
Aberrometer and precision laser systems are affected by a remote code execution vulnerability existing when the Microsoft Windows Print Spooler service is enabled, and improperly performs privileged file operations. This could be exploited to run arbitrary code with SYSTEM privileges, allowing for program installation; view/change/deleting data; or creation of new accounts with full user rights.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

iDesign, Model - G300: System AWS (International), System AWS (China), Advanced WaveScan Studio (United States); iDesign Refractive Studio Aberrometer (International) and (United States), Model: G301

Product Codes/Lot Numbers:

G300 with Windows XP. G301 with Windows 7 Embedded System.

Distribution:

Nationwide distribution

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0443-2022

Related Recalls

Aberrometer and precision laser systems are affected by a remote code execution vulnerability existing when the Microsoft Windows Print Spooler service is enabled, and improperly performs privileged file operations. This could be exploited to run arbitrary code with SYSTEM privileges, allowing for program installation; view/change/deleting data; or creation of new accounts with full user rights.

Oct 21, 2021 Other Medical Devices Nationwide View Details →