FDA Device recall Z-0444-2022
Catalys Precision Laser System, Models: Catalys-U (United States), Catalys-I (International), Catalys-C (China)
- FDA Device
- Class II
- ongoing
- Published 2022-01-05
On 2022-01-05 the FDA classified a Class II recall of Catalys Precision Laser System, Models: Catalys-U (United States), Catalys-I (International), Catalys-C (China) 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-0444-2022 |
| 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
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)
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 | Catalys-U and Catalys-I with Windows 7 Ultimate/Professional/Embedded Standard. Catalys-C with Windows 7 Embedded Stand…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. |
|---|
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-0444-2022%22
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