Centricity Radiology RA600
Check against the official notice below — it lists the full affected range.
GE Healthcare is recalling its Centricity Radiology RA600 software due to a potential defect affecting measurement accuracy. The software may display inaccurate Distance and Area measurements when these measurements are performed on magnified images. Additionally, for the ZFP version specifically, Distance and Area measurements can be inaccurate when performed on lossy images that have been scaled down from their original resolution. Approximately 1,332 units have been distributed worldwide and across all U.S. states, as well as internationally to multiple countries including Canada, Australia, and Brazil.
The recall affects software versions 7.0 through 7.0 SP and versions 8.0 through 8.0 SP14H. The record does not specify a remedy 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: 1,332 units Lot/code info: a. Software Version 7.0 through 7.0 SP, No GTIN/DI (Code: 2022296-0XX); b. Software Version 8.0 through 8.0 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.