Recall archive / FDA device enforcement
(1) GE Centricity Universal Viewer 6.0, Model 2088026-9XX; (2) GE Centricity Universal Viewer 7.0, Model 5826659-0XX;... — FDA record Z-1566-2022
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jul 15, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- (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
- Inaccurate Distance and Area measurements with use of Global Stack viewport.
- Classification
- Class II
- Recalling firm
- GE Healthcare, LLC
- Quantity
- 1,690 devices
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1566-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | (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. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
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.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Arkansas
- Arizona
- California
- Colorado
- Delaware
- Florida
- Georgia
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Missouri
- Mississippi
- Montana
- North Carolina
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Vermont
- Washington
- Wisconsin
- West Virginia
Dates in the source
- Report date
- Aug 31, 2022
- Recall initiation date
- Jul 15, 2022
- Center classification date
- Aug 24, 2022
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.