Recall Z-1182-2016 ยท LLZ System, Image Processing, Radiological
Mckesson Medical Immaging
McKesson Horizon Medical Imaging (HMI) products versions 4.6.1 to including 11.9 and McKesson Radiology (MR) products 12.0 and 12.1.1.
| Date | Feb 18, 2016 |
| Status | Terminated |
| Reason | McKesson has identified a design deficiency where under rare circumstances, imported images/studies may re-use a non-unique image directory. This issue may cause incorrect images to be displayed for a patient. |
| Root cause | Software design |
| Action | McKesson sent an Urgent Field Safety Notice dated February 18, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Immediate actions to take to reduce the risk to patient All customers receiving this safety notice must contact McKesson Support as soon as possible at 1-800-663-2533 US/Canada and International Toll Free Radiology - 00 800 626 20009: 1) To acknowledge that they have read and understood this Field Safety Notice And 2) Arrange installation of software update/upgrade. This notice should be distribu |
| Quantity | 631 devices |
| Distribution | Worldwide Distribution - USA (nationwide) including Puerto Rico and to the states of : AL, AK, AZ, AR, CA, CO, 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 the countries of : Guam, Gr |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K043146 | HORIZON MEDICAL IMAGING Mckesson Medical Imaging Company, Jan 4, 2005 |