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U.S. Department of Health and Human Services

Class 2 Device Recall GE Healthcare Inc.

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  Class 2 Device Recall GE Healthcare Inc. see related information
Date Initiated by Firm August 11, 2015
Date Posted August 27, 2015
Recall Status1 Terminated 3 on January 05, 2017
Recall Number Z-2469-2015
Recall Event ID 71964
Product Classification System, image processing, radiological - Product Code LLZ
Product Centricity PACS-IW with Universal Viewer

Product Usage: The Centricity PACS-IW with Universal Viewer 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.
Code Information Model Number: Centricity PACS-IW with Universal Viewer Version 5.0 through 5.0 SP7  Codes: 2090255-001 UV 6.0 Web Client Media Kit. 05 Jun 15 to present  
Recalling Firm/
Manufacturer
GE Healthcare
540 W Northwest Hwy
Barrington IL 60010-3051
For Additional Information Contact Deb Lahr
847-277-4472
Manufacturer 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.
FDA Determined
Cause 2
Software design (manufacturing process)
Action The firm sent out an Urgent Medical Device Correction letter dated 8/11/2015 to all affected customers. Letter states that No User activity required. GE Healthcare has completed a remote inspection of your system and found that this system parameter is currently set to the default setting of 1. The firm will correct all affected systems by a providing software update. The letter also states that if the customer has any questions they should call GE Healthcare Service at 1-800-437-1171 or their local service representative.
Quantity in Commerce 82 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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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