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GE Healthcare, LLC Recall 88959

Description: GE Centricity Universal Viewer Zero Footprint Client

GE Healthcare, LLC Recall 88959 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0329-2022
Event ID88959
Event DescriptionGE Centricity Universal Viewer Zero Footprint Client
Product TypeDevices
DistributionWorldwide 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.
Quantity638 devices
Recall ReasonThere is a potential to display incomplete patient imaging study.
Device Classification20211208
Device Code InfoVersions 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 Date20211202
Recall Initiation Date20211015
Recalling FirmGE Healthcare, LLC
Initial Notification Letter
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