Z-1566-2022 Class II Ongoing

Recalled by GE Healthcare, LLC — Waukesha, WI

Recall Details

Product Type
Devices
Report Date
August 31, 2022
Initiation Date
July 15, 2022
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1,690 devices

Product Description

(1) GE Centricity Universal Viewer 6.0, Model 2088026-9XX; (2) GE Centricity Universal Viewer 7.0, Model 5826659-0XX; (3) GE Universal Viewer 8.0, Model 5865740-00x.

Reason for Recall

Inaccurate Distance and Area measurements with use of Global Stack viewport.

Distribution Pattern

Distribution was made to AR, AZ, CA, CO, DE, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, ME, MI, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VT, WA, WI, and WV. There was government distribution and no military distribution. Foreign distribution was made to Argentina, Aruba, Australia, Bahrain, Belgium, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Dominican Republic, Ecuador, Egypt, France, Germany, Ghana, Hong Kong, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, South Korea, Kuwait, Lebanon, Malaysia, Malta, Mexico, Netherlands, Panama, Peru, Poland, Qatar, Russia, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Turkey, United Arab Emirates, United Kingdom, and Vietnam.

Code Information

(1) Centricity Universal Viewer 6.0 - UDI 00840682103800; Software versions 6.0 SP9, 6.0 SP9.0.1 through 6.0 SP9.0.1.11, 6.0 SP9.0.2, and 6.0 SP10 through 6.0 SP10.4. (2) Centricity Universal Viewer 7.0 - UDI 00840682145794, 00840682145558; Software versions 7.0 through 7.0 SP0.0.4.9, 7.0 SP0.0.5, 7.0 SP0.1.0, and 7.0 SP1. (3) Universal Viewer 8.0 - UDI 00195278379610; Software versions 8.0, 8.0 SP0.1.0, and 8.0 SP0.1.1.