GE Healthcare, LLC Recall 90136
Description: Centricity Universal Viewer Zero Footprint Client
GE Healthcare, LLC Recall 90136 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1229-2022 |
| Event ID | 90136 |
| Event Description | Centricity Universal Viewer Zero Footprint Client |
| Product Type | Devices |
| Distribution | Worldwide distribution. Nationwide distribution to AL, AR, AZ, CA, CO, CT, DC, 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, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. International distribution to Argentina, Australia, Austria, Bahamas, Belgium, Bermuda, Bolivia, Plurinational State of, Brazil, Canada, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Germany, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Kazakhstan, Korea, South, Kuwait, Lebanon, Malaysia, Malta, Mexico, Namibia, Netherlands, Nigeria, Norway, Pakistan, Panama, Peru, Poland, Portugal, Puerto Rico, Qatar, Russia, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad And Tobago, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Bolivarian Republic of, Vietnam |
| Quantity | 488 units |
| Recall Reason | Potential for Distance and Area measurements to display inaccurate measurement values when performed on magnified images, and specific to ZFP, Distance and Area measurements can display inaccurate measurement values when performed on lossy images that are scaled down from their original resolution. |
| Device Classification | 20220615 |
| Device Code Info | Software Version 6.0 SP11 through 6.0 SP11.4; GTIN/DI: 00840682102988; Codes: 2089507-1XX |
| Center Classification Date | 20220603 |
| Recall Initiation Date | 20220428 |
| Recalling Firm | GE Healthcare, LLC |
| Initial Notification | Letter |
| Similar To |