GE Healthcare, LLC Recall 88959
Description: GE Centricity Universal Viewer Zero Footprint Client
GE Healthcare, LLC Recall 88959 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0329-2022 |
| Event ID | 88959 |
| Event Description | GE Centricity Universal Viewer Zero Footprint Client |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of AR, AZ, CA, CO, DE, FL, GA, IL, IN, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, WA, and WV. The countries of Argentina, Aruba, Australia, Belgium, Bolivia, Brazil, Canada, Chile, China, Colombia, Dominican Republic, Ecuador, France, Germany, India, Indonesia, Ireland, Israel, Italy, Japan, Korea, Kuwait, Lebanon, Malaysia, Mexico, Panama, Qatar, Russia, Saudi Arabia, South Africa, Spain, Switzerland, Taiwan, Trinidad and Tobago, Turkey, United Arab Emirates, United Kingdom, and Vietnam. |
| Quantity | 638 devices |
| Recall Reason | There is a potential to display incomplete patient imaging study. |
| Device Classification | 20211208 |
| Device Code Info | Versions 6.0 SP9, SP9.0.1, SP9.0.1.1, SP9.0.1.2, SP9.0.1.3, SP9.0.1.4, SP9.0.1.5, SP10, SP10.1, SP10.2, SP10.2.1, SP10.2.1.1, SP10.2.2, SP10.2.2.1 configured with a Centricity PACS back end. GTIN 00840682102988; UDI 00840682102988. |
| Center Classification Date | 20211202 |
| Recall Initiation Date | 20211015 |
| Recalling Firm | GE Healthcare, LLC |
| Initial Notification | Letter |
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