Z-1728-2014 Class II Terminated
FDA device recall Z-1728-2014 was initiated by Mckesson Medical Immaging on May 29, 2014 and is designated Class II. Reason for recall: Firm received a complaint that an unreported study performed that day could not be opened from the archive. The recall status is terminated (terminated March 31, 2017). Affected quantity: 659.
Recall Details
- Product Type
- Devices
- Report Date
- June 18, 2014
- Initiation Date
- May 29, 2014
- Termination Date
- March 31, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 659
Product Description
Horizon Medical Imaging Horizon Medical Imaging 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
Firm received a complaint that an unreported study performed that day could not be opened from the archive.
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, NJ, NM, NY, NC, ND, OH, OR, PA, RI, SC, TN, TX, VT, VA, WA, WV, WI, WY, and Puerto Rico. Internationally to Australia, Canada, France, Great Britain,and Guam.
Code Information
HMI 4.6.1, HMI 5.0 (Service Pack 1: Service Pack 5; Service Pack 7; Service Pack 8), HMI 11.0 (11.0.3; 11.0.4; 11.0.5; 11.0.6; 11.0.6 FR EXP2; 11.0.7; 11.0.8), HMI 11.5 (11.5.1; 11.5.2), HMI 11.6, HMI 11.7, HMI 11.8, HIM 11.9, McKesson Radiology 12.0