Horizon Medical Imaging system. Product Usage: Horizon Medical Imaging is a medical image and information management app
FDA device recall Z-2238-2012 · posted 2012-08-22 · Terminated
Recall details
- Recalling firm
- Mckesson Medical Imaging Group
- Reason for recall
- There is a potential to save reports in RadReport with an Incorrect Final Status.
- Action taken
- McKesson sent an Urgent Field Safety Notice letter dated May 29, 2012 to all affected consignees. The letter identified the affected product, circumstances under which the issue occurs and immediate actions to be taken. Customers were advised to notify the Customer Support department that they have read and understood this Advisory Notice at 1-800-663-2533. For questions contact the Support Manager at the Customer Support department.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 516 units
- Distribution
- Worldwide Distribution - U.S. Nationwide and the countries of: Canada, France, Ireland and United Kingdom.
- Date initiated
- 2012-05-29
- Date posted
- 2012-08-22
- Date terminated
- 2013-09-12
- Location
- 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 |