Centricity PACS RA1000
Check against the official notice below — it lists the full affected range.
GE Healthcare, LLC is recalling the Centricity PACS RA1000 system because Distance and Area measurements may display inaccurate values when performed on magnified images. For systems using the ZFP component, measurements can also be inaccurate when performed on lossy images that have been scaled down from their original resolution. The recall affects 676 units distributed worldwide and throughout the United States, involving software versions 3.0 through 7.0 across multiple software updates identified by specific code numbers.
The source document does not specify a remedy or corrective 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: 676 units Lot/code info: a. Software Version 3.0 through 3.2 SP8, No GTIN/DI (Code: 2051372-0XX, 2064678-0XX) b. Software Version 4.0 through 4.0 SP14, GTIN/DI 00840682124447 (Code: 2062264-0XX); c. 6.0 through 6.0 SP10.3, GTIN/DI: 00840682104821 (Code: 2094628-0XX); d. 7.0 through 7.0 SP0.0.4.7, GTIN/DI: 00840682145558 (Code: 5824366-0XX)
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.