Recall Z-0118-2014 ยท LLZ System, Image Processing, Radiological
Ge Healthcare It
Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations. Lossy compressed mammographic images and digitized film screen images may only be interpreted
| Date | Oct 30, 2013 (initiated Jun 15, 2012) |
| Status | Terminated |
| Reason | Multiple issues were identified with the GE Centricity PACS-IW system that could pose a safety risk to patients. These issues include: 1) With Auto-Fetch in use another patient's image may appear without user's intention. 2.a) In the case where dose administration time and image acquisition time fall on either side of midnight, the value will be under reported and close to zero for all pixe |
| Root cause | Software design |
| Action | GE Healthcare sent an IMPORTANT PRODUCT INFORMATION letter dated June 15, 2012 to direct accounts informing them of the Auto-Fetch functionality issue and advising them to discontinue the use of the Auto-Fetch feature and to change the system setting to not allow users privileges to use Auto-Fetch. Customers were requested to contact their Field Engineer or GE Service Representative with any questions or to call the GE Healthcare Remote Online Center Customer Care Center at 1-800-437-1171. GE Healthcare sent an URGENT MEDICAL DEVICE CORRECTION letter dated March 12, 2013 to all affected cust |
| Quantity | 847 units |
| Distribution | Worldwide Distribution - USA including AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, District of Columbia, Puerto Rico, and the U.S. Virgin Islands. Inte |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K083018 | CENTRICITY PACS WEB DIAGNOSTIC Ge Healthcare Dynamic Imaging Solutions, Nov 14, 2008 |