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Recall Observatory FDA recall evidence

Device product

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

Z-2502-2021

August 06, 2021

Class II

Product summary

Firm
GE Healthcare, LLC
Event
Event 88526
Status
Ongoing
Classification
Class II
Quantity
392 (219 US; 173 OUS) all products
Official record key
device-enforcement:Z-2502-2021

Official wording

Reason: Image acquisition failures and synchronization failure with the Centricity Enterprise Archive

Code information: 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

Distribution pattern: 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 and WY. Austria, Brazil, Canada, France, Germany, Ghana, India, Ireland, Israel, Italy, Kuwait, Netherlands, Panama, Poland, Russia, Saudi Arabia, Slovenia, South Africa, Spain, Switzerland, Turkey, United Kingdom and Uruguay.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Image acquisition failures and synchronization failure with the Centricity Enterprise Archive