Centricity recallZ-1566-2022 · GE Healthcare, LLC · initiated Jul 15, 2022

Why it was recalled

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

FDA root cause category: Process design

What the company is doing

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.

Recall details

Recall number

Z-1566-2022

Status

Open, Classified

Initiated by the company

Jul 15, 2022

Posted by the FDA

Aug 24, 2022

Recalling firm

GE Healthcare, LLC

Quantity

1,690 devices

Product code

LLZ

FDA submissions

K150420, K182419, K211312

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.

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.

Devices named in this recall

4 devices in the FDA device registry whose identifier appears in the recall's code information.

• CENTRICITY UNIVERSAL VIEWER 6.0

  Ge Healthcare · System, image processing, radiological
  8 recalls0 reports
• CENTRICITY UNIVERSAL VIEWER 7.0

  Ge Healthcare · System, image processing, radiological
  6 recalls0 reports
• Centricity CPACS 7.0

  Ge Healthcare · Laparoscope, general & plastic surgery
  2 recalls1 report
• Universal Viewer 8

  Ge Healthcare · System, image processing, radiological
  2 recalls0 reports

Product lines

• CentricityGe Healthcare · 9 models · 1 reports · 25 recalls