Unrated Medical device recall · FDA · Published October 21, 2021

AMO iDesign G300 Systems Recall: Remote Code Vulnerability Risk

AMO recalls iDesign G300 systems due to a remote code vulnerability in Windows Print Spooler that could allow unauthorized program installation and data access. Affected units include specific models sold internationally and in the US.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0443-2022Medical device AMO ›

Recall notice

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.

Take action

Contact the company

Recalling firmAMO Manufacturing USA, LLC510 Cottonwood Dr · Milpitas, CA 95035-7403

✎ GovInfoNow plain-language explainer

AMO is recalling iDesign G300 systems that have a security vulnerability in their software. This could let attackers run programs with full system control, potentially accessing or changing your data without permission. Read more at govinfonow.com/recall/61637-amo-idesign-g300-systems-recall-remote-code-vulnerability-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/61637-amo-idesign-g300-systems-recall-remote-code-vulnerability-risk · Updated August 18, 2026 · FDA enforcement record: FDA #Z-0443-2022

Cite this page

“AMO iDesign G300 Systems Recall: Remote Code Vulnerability Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/61637-amo-idesign-g300-systems-recall-remote-code-vulnerability-risk. Based on FDA recall #Z-0443-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0443-2022%22&limit=1).

The FDA announced on Oct. 21, 2021, that AMO Manufacturing USA, LLC voluntarily recalled iDesign Aberrometer and precision laser systems due to a remote code execution vulnerability. This flaw allows unauthorized users to run arbitrary code with SYSTEM privileges, potentially installing programs or altering data. Owners should contact the company for remedy details.

How to tell if you have it

Brand: AMO
Product: iDesign, Model - G300: System AWS (International), System AWS (China), Advanced WaveScan Studio (United States)
Product: iDesign Refractive Studio Aberrometer (International) and (United States), Model: G301
Product: G300 with Windows XP
Product: G301 with Windows 7 Embedded System
Quantity: 711 units

The hazard

The Aberrometer and precision laser systems are affected by a remote code execution vulnerability when the Microsoft Windows Print Spooler service is enabled. This vulnerability allows improper performance of privileged file operations, enabling exploitation to run arbitrary code with SYSTEM privileges. Such exploitation could allow for program installation, viewing or changing data, or creation of new accounts with full user rights.

How to tell if you have this one

Check if your iDesign G300 system has Windows XP or Windows 7 Embedded System. Affected models include System AWS (International), System AWS (China), Advanced WaveScan Studio (US), and Refractive Studio Aberrometer (G300/G301).

Brand
AMO
Category
Medical device

FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
US: CA, TX, FL, LA, MD, IA, MA, VA, SD, MN, MO, NC, TN, SC, WA, NV, OH, KY, IN, CO, NJ, OK, NH, UT, AR, NY, AK, ND, NE, IL, AL, HI, CT, DE, KS, GA, OR, MS, PA, MT, ME, MI, AZ, ID, WI, VT, NM, CA. OUS: Canada, Mexico, Russian Federation, Turkey, Brazil, Egypt, Iraq, Saudi Arabia, Jordan, Norway, Colombia, Germany, Malaysia, India, Oman, Azerbaijan, Canada, Slovakia, Lebanon, Spain, Ireland, Italy, South Korea, Bangladesh, Chile, Taiwan, Tunisia, Kazakhstan, Libya, Argentina, Singapore, Austria, Australia, Vietnam, Greece, Poland, Indonesia, Yemen, Great Britain, South Africa, Croatia, France, Czech Republic, Algeria, Thailand, Bulgaria, United Arab Emirates, Belgium, Japan, China, Nepal, Israel, Switzerland, Dominican Republic, Hong Kong, Portugal, Ecuador, Kuwait, Netherlands, Slovenia, Philippines

Recall number	Product, codes & lots	Quantity
Z-0443-2022	iDesign, Model - G300: System AWS (International), System AWS (China), Advanced WaveScan Studio (United States); iDesign Refractive Studio Aberrometer (International) and (United States), Model: G301; G300 with Windows XP. G301 with Windows 7 Embedded System.	711
Z-0444-2022	Catalys Precision Laser System, Models: Catalys-U (United States), Catalys-I (International), Catalys-C (China); and Catalys Precision Laser System No Bed, Models: 0160-6020 (United States), 0160-6010 (International); 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.	546

Based on the official FDA remedy

What to do — step by step

Check System Version
Verify your system uses Windows XP or Windows 7 Embedded System to confirm if it's affected.

Where it went and when

Where it was distributed

Distributed in 47 states, and outside the U.S.

FDA distribution: “US: CA, TX, FL, LA, MD, IA, MA, VA, SD, MN, MO, NC, TN, SC, WA, NV, OH, KY, IN, CO, NJ, OK, NH, UT, AR, NY, AK, ND, NE, IL, AL, HI, CT, DE, KS, GA, OR, MS, PA, MT, ME, MI, AZ, ID, WI, VT, NM, CA. OUS: Canada, Mexico, Russian Federation,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, Wisconsin.

Recall timeline

FDA published this recall 2 months after the firm started it.

Oct 21, 2021Firm started the recall
Dec 29, 2021FDA classified it Class II
Jan 5, 2022Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/61637-amo-idesign-g300-systems-recall-remote-code-vulnerability-risk">AMO iDesign G300 Systems Recall: Remote Code Vulnerability Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0443-2022 (October 21, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0443-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.