McKesson Radiology-PACS. McKesson Radiology is a medical image and information application that is intended to receive,
FDA device recall Z-1617-2014 · posted 2014-05-13 · Terminated
Recall details
- Recalling firm
- Mckesson Medical Immaging
- Reason for recall
- High priority alert icon was not displayed in the Study List when there are no Stat studies present. However, the High priority alert icon is visible when studies marked as Stat priority exist in the Study List.
- Action taken
- On April 17, 2014, McKesson Medical Imaging Company initiated a process for applying a software solution to all McKesson Radiology customer systems that may be affected to prevent future occurrences of this issue. The systems with the potentially affected software versions will be corrected without removing the systems from their location.
- Root cause
- Software Design Change
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 45
- Distribution
- Worldwide Distribution-USA (nationwide) including the states of AL, CA, GA, ID, IL, IA, MD, MS, MO, NE, NV, NH, NY, NC, PA, TN, TX, VT, WA, WV, WY, and the countries of Canada and France.
- Date initiated
- 2014-04-17
- Date posted
- 2014-05-13
- Date terminated
- 2016-02-02
- 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 |