Z-2121-2014 Class II Terminated
FDA device recall Z-2121-2014 was initiated by Mckesson Medical Immaging on May 5, 2014 and is designated Class II. 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. The recall status is terminated (terminated April 13, 2017). Affected quantity: 659 units.
Recall Details
- Product Type
- Devices
- Report Date
- August 6, 2014
- Initiation Date
- May 5, 2014
- Termination Date
- April 13, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product 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.
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