Z-0443-2022 Class II Ongoing
FDA device recall Z-0443-2022 was initiated by AMO Manufacturing USA, LLC on October 21, 2021 and is designated Class II. 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 f… The recall status is ongoing. Affected quantity: 711.
Recall Details
- Product Type
- Devices
- Report Date
- January 5, 2022
- Initiation Date
- October 21, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 711
Product Description
Reason for Recall
Distribution Pattern
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