—#141166

Product

The Centricity Universal Viewer Version is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed and displayed within the system or across computer networks at distributed locations. Typical users of this system are trained professionals, including but not limited to radiologists, physicians, nurses, medical technicians, and assistants.

FDA product code: LLZ — System, Image Processing, Radiological
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K150420
Affected lot / code info: 2088034-001 DVD UNIVERSAL VIEWER 6.0 - WEB CLIENT

Why it was recalled

Inaccurate distance measurements with magnified projection X-ray images.

Root cause (FDA determination)

Software design

Action the firm took

An URGENT MEDICAL DEVICE CORRECTION letter was sent to all medical users on 9/28/2015 regarding Centricity PACS-IW with Universal Viewer and Centricity Universal Viewer- Inaccurate distance measurements with magnified projection X-ray images. GE Healthcare explains that for all projection X-rays, GE Healthcare recommends that the user perform the necessary measurements on the standard contact images, and not rely on measurements made on the magnified views unless the measurements have been independently verified for each X-Ray machine installed or manually calibrated using a radio-opaque fiducial of a known size. Attention should be given to prior cases acquired before the application of the safety instructions given in this communication as they may be affected by the safety issue. GE Healthcare will correct all affected systems by providing a software update at no cost to the customer. GE Healthcare advises customers if they have any questions or concerns regarding the notification, to please contact 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-US (nationwide) including the states of AZ, CA, CO, DE, FL, GA, IA, IL, IN, LA, MA, MI, MN, MO, NJ, NY, OR, PA, SC, SD, TN, TX, VA, WA, WI and WV, and the countries of Australia, Austria, Bangladesh, Belgium, Brazil, Canada, Chile, China, Ecuador, France, Germany, Ghana, Hong Kong, India, Israel, Italy, Japan, Kenya, Korea, Malta, Malaysia, Namibia, Netherlands, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Turkey, Taiwan, United Arab Emirates, United Kingdom and Venezuela.

Timeline

Recall initiated: 2015-09-28
Terminated: 2018-04-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #141166. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.