FDA Enforcement
Class II
Terminated
McKesson Radiology-PACS. McKesson Radiology is a medical image and information application that is intended to receive, transmit, store, retrieve, display, print and process digital medical images, digital medical video, and associated medical information from various medical imaging systems.
Recall: Z-1617-2014
·
Reported May 21, 2014
Enforcement
- Recall Number
- Z-1617-2014
- Event ID
- 68208
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Mckesson Medical Immaging
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- May 21, 2014
- Initiation Date
- April 17, 2014
- Classification Date
- May 13, 2014
- Termination Date
- February 2, 2016
- Address
- Suite 130-10711 Cambie Road, Richmond, British Columbia, N/A, Canada
Description
McKesson Radiology-PACS. McKesson Radiology is a medical image and information application that is intended to receive, transmit, store, retrieve, display, print and process digital medical images, digital medical video, and associated medical information from various medical imaging systems.
Reason
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.
Code Info
Model MR 12.0
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.
Quantity
45