Artis Q systems; dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures.
Enforcement
- Recall Number
- Z-2341-2015
- Event ID
- 71711
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Siemens Medical Solutions USA, Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- August 12, 2015
- Initiation Date
- June 29, 2015
- Classification Date
- August 5, 2015
- Termination Date
- December 7, 2016
- Address
- 51 Valley Stream Pkwy, N/A, Malvern, PA, 19355-1406, United States
Description
Artis Q systems; dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures.
The possibility exists for a large amount of liquid to seep through the top cover of the table and penetrate the components inside the table. If this occurs, table movements may no longer be possible. No injuries reported.
Model Number of device: 10848282 10848281 10848355 10848354 serial numbers: 121006 121013 109016 121011 123008 123003 123011 121014 109011 121004 121018 121036 121012 109015 109009 121019 121010 121015 121016 109007 111000 121020 121009 121056 121057 109021 121008 109020 109027 109010 123010 121041
US Nationwide
N/A