Horizon Medical Imaging, Picture Archive Communication System (PACS).
FDA device recall Z-0976-2014 · posted 2014-02-12 · Terminated
Recall details
- Recalling firm
- Mckesson Information Solutions LLC
- Reason for recall
- Images may be archived to an incorrect or invalid archive location resulting in incorrect images or no images being displayed for a study following retrieval from archive.
- Action taken
- McKesson sent a field notice to customers with the potentially affected software versions on 12/23/2013.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 618 units
- Distribution
- U.S. Nationwide (Puerto Rico), Australia, Canada, France, GU, IE, and The United Kingdom.
- Date initiated
- 2013-12-23
- Date posted
- 2014-02-12
- Date terminated
- 2017-04-25
- Location
- Alpharetta, GA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HORIZON MEDICAL IMAGING (K043146) | Mckesson Medical Imaging Company | 2005-01-04 |