PlainRecalls
FDA Devices Moderate Class II Terminated

Centricity Universal Viewer Product Usage: The Centricity Universal Viewer Version 6.0 software is a picture archiving and communications system, a device that provides one or more capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images. Its hardware components may include workstations, digitizers, communications devices, computers, video monitors, magnetic, optical disk, or other digital data storage devices, and hardcopy devices. The so

Reported: September 2, 2015 Initiated: August 11, 2015 #Z-2470-2015

Product Description

Centricity Universal Viewer Product Usage: The Centricity Universal Viewer Version 6.0 software is a picture archiving and communications system, a device that provides one or more capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images. Its hardware components may include workstations, digitizers, communications devices, computers, video monitors, magnetic, optical disk, or other digital data storage devices, and hardcopy devices. The software components may provide functions for performing operations related to image manipulation, enhancement, compression or quantification. Used in Radiology.

Reason for Recall

Images from the Centricity PACS-IW with Universal Viewer and Centricity Universal Viewer may be missing when a system parameter MapRoute is set to a value greater than 1.

Details

Recalling Firm
GE Healthcare
Units Affected
26 systems
Distribution
Worldwide Distribution - U.S. nationwide in the states of: AK, CA, CO, DE, FL, HI, ID, NY, PA, SD, TN and TX; France, Germany, Greece, India, Israel, Malaysia, Mexico, Northern Ireland (UK), Panama, Poland, Russia, South Africa, Saudi Arabia, Switzerland, Turkey, UAE and Uruguay.
Location
Barrington, IL

Frequently Asked Questions

What product was recalled? ▼
Centricity Universal Viewer Product Usage: The Centricity Universal Viewer Version 6.0 software is a picture archiving and communications system, a device that provides one or more capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images. Its hardware components may include workstations, digitizers, communications devices, computers, video monitors, magnetic, optical disk, or other digital data storage devices, and hardcopy devices. The software components may provide functions for performing operations related to image manipulation, enhancement, compression or quantification. Used in Radiology.. Recalled by GE Healthcare. Units affected: 26 systems.
Why was this product recalled? ▼
Images from the Centricity PACS-IW with Universal Viewer and Centricity Universal Viewer may be missing when a system parameter MapRoute is set to a value greater than 1.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 2, 2015. Severity: Moderate. Recall number: Z-2470-2015.

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