—#195318

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.

FDA product code: LLZ — System, Image Processing, Radiological
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K150420, K182419, K211312
Affected lot / code info: (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.

Why it was recalled

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

Root cause (FDA determination)

Process design

Action the firm took

The recalling firm issued letters dated 7/15/2022 via traceable means on 7/15/2022 to the following titles within their affected accounts: Director/Manager of Radiology, Director/Manager of Cardiology, Risk Manager/Hospital Administrator, Head of Radiology Department, Head of Cardiology Department, PACS Administrator, Director of IT Department, Head of Biomedical Engineering, Head of Imaging Informatics. The letter explained the issue, the affected product details, and the actions to be taken by the customer/user, which included the following: The customer/user can continue to use the system in accordance with User Manuals and the following actions: It is recommended the customer/user does not rely on measurements displayed in the Global Stack viewport in the Viewer. Users can perform the measurement activity by (1) Using Overview or Series Viewport to perform the measurement; or (2) If using Global Stack viewport, manually calibrate the image to create a measurement calibration reference and then perform necessary measurements. The customer/user is to complete and return the attachment acknowledgement form to the link in the letter or through the QR code. The customer/user was requested to ensure all potential users in their facility are made aware of this safety notification and the recommended actions. GE Healthcare will correct all affected products and a representative will be in contact with the customer/user to arrange for the correction. After the software has been corrected, the customer/user is to destroy all previous versions of the locally stored application installation package(s) immediately.

Recalling firm

Firm: GE Healthcare, LLC
Address: 3000 N Grandview Blvd, Waukesha, Wisconsin 53188-1615

Distribution

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.

Timeline

Recall initiated: 2022-07-15
Posted by FDA: 2022-08-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #195318. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.