Horizon Medical Imaging It is a medical image and information management application that is intended to receive, transm

FDA device recall Z-2121-2014 · posted 2014-07-28 · Terminated

Recall details

Recalling firm

Mckesson Medical Immaging

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.

Action taken

McKesson sent an Urgent Field Safety Notice dated May 5, 2014, to all affected customers informing them of the issue and advising them of the immediate actions to take to reduce the risk to the patient. These actions include - Users ensure that all expected images are display in the Image Viewer and PACS Administrators should engage McKesson Support for all issues with studies. McKesson is also providing a software solution to HMI systems that may be potentially affected by the problem to prevent future recurrence. Customers were instructed to contact McKesson Support as soon as possible at 1-800-663-2533 to acknowledge that they have read and understood the Field Safety Notice, and to arrange installation of the software update. Customers with questions were instructed to contact Customer Support and ask to speak to their Support Manager. For questions regarding this recall call 404-338-3556.

Root cause

Software design

Status

Terminated

Product code

LLZ

Quantity affected

659 units

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, NM, NJ, NY, NC, ND, OH, OR, PA, RI, SC, TN, TX, V

Date initiated

2014-05-05

Date posted

2014-07-28

Date terminated

2017-04-13

Location

Richmond Canada, British Columbia

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