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

FDA device recall Z-1566-2022 · posted 2022-08-24 · Open, Classified

Recall details

Recalling firm

GE Healthcare, LLC

Reason for recall

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

Action taken

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.

Root cause

Process design

Status

Open, Classified

Product code

LLZ

Quantity affected

1,690 devices

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 g

Date initiated

2022-07-15

Date posted

2022-08-24

Location

Waukesha, WI

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