Recall Z-0443-2022— AMO Manufacturing USA, LLC
Class II · Ongoing
Class II FDA medical device recall by AMO Manufacturing USA, LLC, initiated 2021-10-21. FDA's recall record names no specific 510(k) clearance for this event. Product: iDesign, Model - G300: System AWS (International), System AWS (China), Advanced WaveScan Studio (United States); iDesign Refractive Studio Aberrometer (International) and (United States), Model: G301. Reason: 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..
- Recalling firm
- AMO Manufacturing USA, LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2021-10-21
- Firm location
- Milpitas, CA, United States
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
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.