medical Class II Updated 2021-09-29

GE Healthcare, LLC recalls Centricity PACS-IW with Universal Viewer - Product Usage: Is

Recalled Product

Centricity PACS-IW with Universal Viewer - Product Usage: Is a device that displays medical images (including mammograms) and data from various imaging sources.


Hazard / Issue

Image acquisition failures and synchronization failure with the Centricity Enterprise Archive

Issued by

FDA

Affected States: AK, AZ, CA, CO, DE, FL, GA, IA, IN, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TX, UT, WA, WI, WV, WY
Lot/Code Info: 2068177-001 (Centricity PACS-IW with Universal Viewer software versions 5.0.x with PACS-IW foundation) System ID: 083055248481416, 1-121967267, 1-429329281, DGC19607785, HC3062UV01, HCIT1401012UW, HCIT4331279UV, PACS-IW-127, PACS-IW-219, PACS-IW-2770, PACS-IW-323, PACS-IW-421, RICHMONDU14767331, RICHMONDU15531177N1, X1347906 / X1347909, X1347906 / X1347909, YP315021, ZA2412PAC21 and ZA2533PAC1
View official government recall

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