FDA Device recall Z-0443-2022
iDesign, Model - G300: System AWS (International), System AWS (China), Advanced WaveScan Studio (United States)
- FDA Device
- Class II
- ongoing
- Published 2022-01-05
On 2022-01-05 the FDA classified a Class II recall of iDesign, Model - G300: System AWS (International), System AWS (China), Advanced WaveScan Studio (United States) by Amo Manufacturing Usa, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0443-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-10-21 |
| Published | 2022-01-05 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Amo Manufacturing Usa |
| Distribution | AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI |
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.
Identifiers
| code_info | G300 with Windows XP. G301 with Windows 7 Embedded System. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0443-2022%22
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