Device product
Artis one fluoroscopic x-ray system and patient table Artis one is an angiography system developed for diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Arts 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 i.e. patient extremities.
Z-1148-2018
Product summary
- Event
- Event 79538
- Status
- Terminated
- Classification
- Class II
- Quantity
- 16
- Official record key
device-enforcement:Z-1148-2018
Official wording
Reason: Certain patient table systems may have a missing or incorrectly installed snap ring that could cause the bolt to slide out of its base and the tabletop carriage to slide to the floor.
Code information: Serial numbers: 82044 82105 82070 82213 82054 82040 82038 82205 82065 82267 82108 82010 82039 82109 82102 82066
Distribution pattern: US Distribution to the states of : AL, AR, CA, FL, IN, LA, MI, MO, NC, NY, PA, TX, and WA.
Derived failure modes
-
Unknown
Certain patient table systems may have a missing or incorrectly installed snap ring that could cause the bolt to slide out of its base and the tabletop carriage to slide to the floor.