| Class 2 Device Recall GE Healthcare Inc. | |
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
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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
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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 |
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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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