Artis One; The Artis One is an angiography system developed for diagnostic interventional procedures including, but not limited to pediatric and obese patients. Procedures that can be performed with the Artis One include cardiac angiography, neuro-angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures as well as procedures next to the table for patient extremities. Additionally, angiographic procedures can be performed in the operating room, image guided surgery by x-ray, by image fusion, and by navigation systems.
Enforcement
- Recall Number
- Z-1119-2015
- Event ID
- 70342
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Siemens Medical Solutions USA, Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- February 25, 2015
- Initiation Date
- January 16, 2015
- Classification Date
- February 17, 2015
- Termination Date
- April 21, 2015
- Address
- 51 Valley Stream Pkwy, Malvern, PA, 19355-1406, United States
Description
Artis One; The Artis One is an angiography system developed for diagnostic interventional procedures including, but not limited to pediatric and obese patients. Procedures that can be performed with the Artis One include cardiac angiography, neuro-angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures as well as procedures next to the table for patient extremities. Additionally, angiographic procedures can be performed in the operating room, image guided surgery by x-ray, by image fusion, and by navigation systems.
The possibility exists that the monitor may fail and requires a power circle (shutdown and then power on) to resume operation. The problem is not systematic; but sporadic on single units.
Model Number 10848600, serial number 82010
Nationwide Distribution to MI only
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