Recall Z-0225-2016 ยท LLZ System, Image Processing, Radiological
GE Healthcare
The Centricity PACS-IW with Universal Viewer 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,
| Date | Sep 28, 2015 |
| Status | Terminated |
| Reason | Inaccurate distance measurements with magnified projection X-ray images. |
| Root cause | Software design |
| Action | 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 fidu |
| Quantity | Centricity PACS-IW with Universal Viewer Versions 5.0 SP2 and higher 1052 units |
| Distribution | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123174 | CENTRICITY PACS-IW WITH UNIVERSAL VIEWER GE Healthcare, Nov 16, 2012 |