Centricity Cardiology CA1000
Check against the official notice below — it lists the full affected range.
GE Healthcare recalled its Centricity Cardiology CA1000 software due to a potential issue where Distance and Area measurements may display inaccurate values when performed on magnified images. Additionally, for the ZFP component specifically, Distance and Area measurements can show inaccurate values when performed on lossy images that have been scaled down from their original resolution. The recall affected 601 units of software versions 1.0 through 1.0 SP and versions 2.0 through 2.0 SP14H, which were distributed worldwide and throughout the United States, as well as internationally to countries including Canada, Australia, Brazil, and China.
The source document does not specify a remedy or recommended action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Potential for Distance and Area measurements to display inaccurate measurement values when performed on magnified images, and specific to ZFP, Distance and Area measurements can display inaccurate measurement values when performed on lossy images that are scaled down from their original resolution.
Reason for recall: Potential for Distance and Area measurements to display inaccurate measurement values when performed on magnified images, and specific to ZFP, Distance and Area measurements can display inaccurate measurement values when performed on lossy images that are scaled down from their original resolution. Distribution: Worldwide distribution. Nationwide distribution to AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. International distribution to Argentina, Australia, Austria, Bahamas, Belgium, Bermuda, Bolivia, Plurinational State of, Brazil, Canada, Chile, China Quantity: 601 units Lot/code info: a. Software Version 1.0 through 1.0 SP, No GTIN/DI (Code: 2022296-0XX); b. Software Version 2.0 through 2.0 SP14H, GTIN/DI: 00840682125260 (Codes: 2038437-0XX, 2097190-0XX)
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.