Merge Mammo is a multi-modality, vendor-neutral digital mammography workstation that enables imag...
FDA Device Recall #Z-0748-2014 — Class II — August 26, 2013
Recall Summary
| Recall Number | Z-0748-2014 |
| Classification | Class II — Moderate risk |
| Date Initiated | August 26, 2013 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | GE Healthcare It |
| Location | Barrington, IL |
| Product Type | Devices |
| Quantity | 28 units |
Product Description
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 management display needs in the medical environment from multiple locations within and outside the hospital. Productivity-Enhancing Second Console Workstations - Workstations designed to perform automated, routine tasks such as image review, printing and archiving as well as post processing capabilities that enable special services for referring physicians. Diagnostic Review Workstations - Workstations designed to assist radiologists and surgeons in conducting primary diagnostic review and planning through flexible and interactive manipulation of multi-modal softcopy image including the use of prosthetic template overlays, and including mammography. Physician's Review Workstations - Workstations designed to give easy and economic access to multi-modality softcopy images in multiple locations within and outside the hospital. (e.g. teleconferencing, teleradiology etc.) Lossy compressed mammographic images must not be used for primary diagnostic interpretation unless approved for use in digital mammography. Display monitors used for primary diagnostic interpretation of mammographic images must be approved for use in digital mammography.
Reason for Recall
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.
Distribution Pattern
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.
Lot / Code Information
Software version 8.0.2
Other Recalls from GE Healthcare It
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0116-2014 | Class II | The Centricity PACS Workstation is intended for... | Jun 11, 2013 |
| Z-0833-2015 | Class II | Centricity Enterprise Archive is a software pro... | Apr 19, 2013 |
| Z-0620-2014 | Class II | The Centricity Laboratory System is intended to... | Mar 12, 2013 |
| Z-0330-2014 | Class II | The Centricity Laboratory System is intended to... | Mar 12, 2013 |
| Z-0337-2014 | Class II | Centricity Perinatal and Centricity Intensive C... | Mar 11, 2013 |
Frequently Asked Questions
A software recall means the device's embedded software or firmware has a defect that could affect its performance or safety. Many software recalls are corrected through firmware updates that can be applied without physically replacing the device. For implantable devices, the update may be delivered wirelessly during a routine clinic visit. For external devices, the manufacturer may provide updated software files or replacement units. Contact your healthcare provider to determine whether your specific device and software version are affected and what action is recommended.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.