Horizon Medical Imaging It is a medical image and information management application that is i...
FDA Device Recall #Z-2121-2014 — Class II — May 5, 2014
Recall Summary
| Recall Number | Z-2121-2014 |
| Classification | Class II — Moderate risk |
| Date Initiated | May 5, 2014 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Mckesson Medical Immaging |
| Location | Richmond, British Columbia |
| Product Type | Devices |
| Quantity | 659 units |
Product Description
Horizon Medical Imaging It is a medical image and information management application that is intended to receive, transmit, store, retrieve, display print and process digital medical images, digital medical video, and associated medical information from various medical imaging systems.
Reason for Recall
The firm has identified a software issue which may cause a discrepancy between the index of images expected by the application, and the actual content of the folder storing the images.
Distribution Pattern
Worldwide Distribution - USA including AL, AK, AZ, AR, CA, CO, CT, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NM, NJ, NY, NC, ND, OH, OR, PA, RI, SC, TN, TX, VT, VA, WA, WV, WI, WY,and France, Canada, Puerto Rico, Guam, Great Britain, Ireland, Australia.
Lot / Code Information
HMI 4.5, HMI 4.6.1, HIM 5.0, HMI 5.0 Service Pack 6, HMI 5.0 Service Pack 7, HMI 5.0 Service Pack 8, HMI 11.0.6, HMI 11.0.6 FR EXP 2, HMI 11.0.7, HMI 11.0.8, HMI 11.5, HMI 11.5.1, HMI 11.5.2, HMI 11.6, HMI 11.7, HMI 11.8, HMI 11.9, MR 12.0
Other Recalls from Mckesson Medical Immaging
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1182-2016 | Class II | McKesson Horizon Medical Imaging (HMI) products... | Feb 18, 2016 |
| Z-1728-2014 | Class II | Horizon Medical Imaging Horizon Medical Imag... | May 29, 2014 |
| Z-1617-2014 | Class II | McKesson Radiology-PACS. McKesson Radiology ... | Apr 17, 2014 |
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.