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Open, Classified

Centricity Universal Viewer, software versions 6.0 SP0 through 6.0 SP7.1; Radiological Image Processing System

FDA Recall Z-0140-2024 · Posted 2023-10-20

Recalling FirmGE Healthcare
Recall StatusOpen, Classified
Product CodeLLZ
Date Initiated2023-09-14
Product Quantity329 units

Reason for Recall

GE HealthCare has become aware of an issue where images from two different patients may be contained in a single study, when stored in Centricity PACS-IW V3.7.x, Centricity PACS-IW with Universal Viewer V5.0 and Centricity Universal Viewer V6.0 with PACS-IW foundation.

Firm Action

GE Healthcare issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 09/14/2023 by letter. The notice explained the problem, risk to the patient, and provided two workaround options for the continued use of the instruments until the software update is ready for installation. Questions: please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative

Root Cause

Software design

Distribution Pattern

US and Austria, Azerbaijan, Bosnia and Herzegovina, Brazil, Canada, Chile, Colombia, France, Germany, India, Ireland, Italy, Kuwait, Malaysia, Netherlands, Netherlands Antilles, Panama, Poland, Russia, Saudi Arabia, Slovenia, South Africa, Spain, Switzerland, United Kingdom, Uruguay, Venezuela, Vietnam

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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