Recall Z-0748-2014 ยท LLZ System, Image Processing, Radiological
GE Healthcare It
Merge Mammo is a multi-modality, vendor-neutral digital mammography workstation that enables imaging centers to use a single workstation to display and read images from different vendors and different acquisition devices, including digital mammography, ultrasound, MRI and CT. Two and three dimensional image review, manipulation, analysis and therapy planning capabilities that support image manage
| Date | Jan 14, 2014 (initiated Aug 26, 2013) |
| Status | Terminated |
| Reason | There is a potential safety issue with the 8.0.2 version software of the Merge (Cedara) Mammo viewer. The Merge Mammo viewer can load and display images not in synch with the selected or highlighted images in the thumbnail navigator. This incorrect image display issue could result in an inaccurate reading on the Merge Mammo workstation. This could result in a missed intervention or mis-diagnosis. |
| Root cause | Software design |
| Action | GE Healthcare sent an URGENT MEDICAL DEVICE CORRECTION letter dated August 26, 2013, to all affected customers. The letter includes important safety instructions for healthcare providers to refer to that can minimize the chance that an incorrect image will be used in the diagnosis or treatment of a patient. The letter further states that a GE Healthcare service representative will contact the customer to schedule a time to install a software update to version 8.0.2 that will correct the software defect.. Customers with any concerns about this defect or recall are encouraged to contact their |
| Quantity | 28 units |
| Distribution | Worldwide Distribution - USA including AK, AR, CA, IA, ID, IL, MI, MS, MT, NJ, NV, NY, OR, PA, SC, TN, WI and Internationally to Israel, Mexico, and Spain. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K040468 | CEDARA I-SOFTVIEW AND CEDARA I-READMAMMO Cedara Software Corp., Apr 23, 2004 |