Centricity PACS-IW with Universal Viewer - Product Usage: Is a device that displays medical images (including mammograms) and data from various imaging sources.
FDA Recall Z-2502-2021 · Posted 2021-09-22
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Recalling FirmGE Healthcare, LLC
Recall StatusOpen, Classified
Product CodeLLZ
Date Initiated2021-08-06
Product Quantity392 (219 US; 173 OUS) all products
Reason for Recall
Image acquisition failures and synchronization failure with the Centricity Enterprise Archive
Firm Action
This issue will be resolved by sending an Urgent Medical Device Correction letter to customers with affected software versions on August 06, 2021. This letter informs customers of the issues and provides safety instructions. GE Healthcare will correct the issue through a product change.
If you have any questions or concerns regarding this notification, please contact GE
Healthcare Service at 1-800-437-1171 or your local Service Representative.
Root Cause
Software design
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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