Recall Z-0444-2022 ยท OOE Ophthalmic Femtosecond Laser
AMO Manufacturing USA, LLC
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)
| Date | Oct 21, 2021 |
| Status | Open, Classified |
| 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. |
| Root cause | Software design |
| Action | On 09/02/21, Microsoft "PrintNightmare" Vulnerability notices were sent to customers informing them of the upcoming software patches to remediate the vulnerability. This notice was posted on the recalling firm's website in the Security Advisories section. On 10/21/21 correction notices started being sent to customers. Customers were informed that Technical Service Representatives would contact then to schedule installation of the Windows OS patch. Customers were asked to do/ensure the following: 1) Complete the customer reply form, 2) To safeguard patients form potential harm and to inform t |
| Quantity | 546 |
| 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, Co |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K113479 | OPTIMEDICA CATALYS PRECISION LASER SYSTEM Optimedica Corporation, Dec 21, 2011 |