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GE Healthcare, LLC Recall 90136

Description: Centricity Enterprise Web

GE Healthcare, LLC Recall 90136 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-1230-2022
Event ID90136
Event DescriptionCentricity Enterprise Web
Product TypeDevices
DistributionWorldwide 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
Quantity536 units
Recall ReasonPotential 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 Classification20220615
Device Code InfoSoftware Versions 3.0 through 3.0 SP14d, 4.0 through 4.0 Spa6c and 4.0 Spa7b; Codes: 2027870-0XX, 2049944-0XX, 2068692-0XX.
Center Classification Date20220603
Recall Initiation Date20220428
Recalling FirmGE Healthcare, LLC
Initial Notification Letter
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