—#139463

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.

FDA product code: LLZ — System, Image Processing, Radiological
Device class: Class 2
Medical specialty: Radiology
Affected lot / code info: 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

Why it was 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.

Root cause (FDA determination)

Software design (manufacturing process)

Action the firm took

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.

Recalling firm

Firm: GE Healthcare
Address: 540 W Northwest Hwy, Barrington, Illinois 60010-3051

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2015-08-11
Posted by FDA: 2015-08-27
Terminated: 2017-01-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #139463. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.