McKesson Horizon Medical Imaging (HMI) Radiological Image Processing System, product versions 4.6.1 to 11.6., is a medic
FDA device recall Z-2318-2013 · posted 2013-09-30 · Terminated
Recall details
- Recalling firm
- Mckesson Information Solutions LLC
- Reason for recall
- Software malfunction may occur resulting in a certain combination of server configurations which has the potential to cause image loss.
- Action taken
- Consignees were notified via Urgent Field Safety Notice dated September 4. MMIC Customer support will be contacting customers known to have a multi-server configuration and will implement the configuration change.
- Root cause
- Software change control
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 329 units
- Distribution
- Worldwide Distribution - United States including the territories of Guam and Puerto Rico and the countries of Canada and France.
- Date initiated
- 2013-09-04
- Date posted
- 2013-09-30
- Date terminated
- 2017-02-06
- 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 |