Device Recall Horizon Medical Imaging

Horizon Medical Imaging (HMI) versions 11.5, 11.5.1, 11.5.2, 11.6 and 11.7.

Radiology Devices

2

No

Worldwide Distribution - U.S. Nationwide and the countries of: Canada, France, Ireland and United Kingdom.

Horizon Medical Imaging system. || Product Usage: || 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 image systems. The medical modalities of these medical imaging systems include, but are not limited to, all modalities supported by ACR/NEMA DICOM 3.0 (specifically including mammographic images). Horizon Medical Imaging is intended to function with a variety of storage systems and printers via DICOM and other computer industry standard interfaces and protocols. Horizon Medical Imaging is indicated for use by trained medical professionals including, but not limited to, radiologist, physicians, and medical technologists. Horizon Medical Imaging is also indicated for use in soft copy diagnostic interpretation of medical images and video by physicians trained in such practice (specifically including soft copy diagnostic interpretation of mammographic images).

HMI 4.5, HMI 4.6.6, HMI5 (Service Pack 1; 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 11.5.1; 11.5.2), HMI 11.6, HMI 11.7, HMI 11.8 and HMI 11.9.

Radiology Devices

2

No

U.S. Nationwide (Puerto Rico), Australia, Canada, France, GU, IE, and The United Kingdom.

Horizon Medical Imaging, Picture Archive Communication System (PACS).

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

Radiology Devices

2

No

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.

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.

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

Radiology Devices

2

No

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.

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.

Horizon Medical Imaging (HMI) versions: 4.5, 4.6.1, 5.0 without PTF-RR310-601, 11.0.3, 11.0.4, 11.0.5, 11.0.6, 11.0.6 FR EXP2 without PTF-HMI11-649, 11.0.7, 11.0.8 without PTF-HMI11-615, 11.5 and 11.5.1 without PTF-HMI115-613. On June 29, 2010 the recall was amended to include: All installations of Horizon Medical imaging (HMI) 11.0.6, 11.0.8 and 11.5.1

Radiology Devices

2

No

Distributed Nationwide (AK, AL, AR, AZ, CA, CO, FL, GA, IN, IA, IL, KY, LA, MA, MD, MI, NC, ND, NE, NM, NY, NV, OH, OR, PA, RI, SC, TN, TX, WY, VA and WV) and Canada

Voiceware clip software update to certain Horizon Medical Imaging Systems. McKesson Medical Imaging Company. Richmond, Canada V6X 3G5. || 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.