FDA recall Z-0140-2024

GE Healthcare · Class II · device

Product

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

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.

Distribution

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

Key facts

Status: Ongoing
Initiation date: 2023-09-14
Report date: 2023-11-01
Voluntary/Mandated: Voluntary: Firm initiated
Location: Chicago, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0140-2024