Reported Jan 5, 2022 · Ongoing

Catalys Precision Laser System, Models: Catalys-U (United States), Catalys-I (International), Catalys-C (China); and…

AMO Manufacturing USA, LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: AMO Manufacturing USA, LLC · 510 Cottonwood Dr · Milpitas, CA · 95035-7403

Is this the product you have?

  • Catalys Precision Laser System
  • ModelsCatalys-U (United States), Catalys-I (International), Catalys-C (China); and Catalys Precision Laser System No Bed
  • Models
    • 0160-6020 (United States)
    • 0160-6010 (International)
Lot codes and dates
  • Catalys-U and Catalys-I with Windows 7 Ultimate/Professional/Embedded Standard. Catalys-C with Windows 7 Embedded Standard. 0160-6020 and 0160-6010 with Windows 7 Professional/Embedded Standard.
Amount recalled
546

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Where it was sold

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:21 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.