iDesign, Model - G300: System AWS (International), System AWS (China), Advanced WaveScan Studio (United States); iDesign
Summary
The FDA issued a Class II for iDesign, Model - G300: System AWS (International), System AWS (China), Advanced by AMO Manufacturing USA, LLC. Reason: Aberrometer and precision laser systems are affected by a remote code execution vulnerability existing when the Microsoft Windows Print Spooler servic.
Details
Source
Device Recall
External ID
Z-0443-2022
Action Date
2022-01-05
Status
Ongoing
Category
device
Product 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
Lot/Code Info: G300 with Windows XP. G301 with Windows 7 Embedded System.
Quantity Affected: 711
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.
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
Type: Voluntary: Firm initiated
Recall Initiated: 2021-10-21
Company
Milpitas, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 90 device recalls issued in the same week, part of 403 device-related FDA actions this month.
AMO Manufacturing USA, LLC has 4 FDA actions in our database, including 2 recalls and 2 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (AMO Manufacturing USA, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does AMO Manufacturing USA, LLC have FDA actions?
AMO Manufacturing USA, LLC has 4 FDA actions in our database, including 2 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0443-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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