FDA Recall Terminated

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.

Recall: Z-1728-2014 · Initiated May 29, 2014

Recall

Recall Number
Z-1728-2014
Event Number
68431
Firm
Mckesson Medical Immaging Suite 130-10711 Cambie Road Richmond Canada British Columbia
FEI Number
3003757840
Product Code
LLZ
Status
Terminated
Root Cause
Software design
Initiated
May 29, 2014
Posted
June 6, 2014
Terminated
March 31, 2017

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

Firm received a complaint that an unreported study performed that day could not be opened from the archive.

Action

McKesson sent an Urgent Field Safety Notice dated May 20, 2014, to all affected customers. The notice identified the product, the problem, and the action to be taken by the customer. Customers were informed that the potentially affected software versions will be corrected without removing the systems from their location. Customers were instructed to distribute the notice to all those within their organization who need to be aware and alert all those affilliated with their organization that are affected by this field safety notice. All customers receiving the Field Safety Notice should contact McKesson Support as soon as possible at 1-800-663-2533 to arrange installation of the software update. Customers with questions should contact the Customer Support Department and ask to speak to their Support Manager.

Distribution

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.

Quantity

659