Horizon Medical Imaging Horizon Medical Imaging is a medical image and information management application that is intend
FDA device recall Z-1728-2014 · posted 2014-06-06 · Terminated
Recall details
- Recalling firm
- Mckesson Medical Immaging
- Reason for recall
- Firm received a complaint that an unreported study performed that day could not be opened from the archive.
- Action taken
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 659
- 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, V
- Date initiated
- 2014-05-29
- Date posted
- 2014-06-06
- Date terminated
- 2017-03-31
- Location
- Richmond Canada, British Columbia
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HORIZON MEDICAL IMAGING (K043146) | Mckesson Medical Imaging Company | 2005-01-04 |