AXIOM Artis or Artis zee system Product Usage: Axiom Artis and Artis zee / zeego are 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
This recall has been terminated (originally issued September 24, 2014).
- Recall Initiated
- June 5, 2014
- Posted
- September 24, 2014
- Terminated
- April 6, 2015
- Recall Number
- Z-2587-2014
- Quantity
- 1067
- Firm Location
- Malvern, PA
- Official Source
- View on FDA website ↗
Reason for Recall
There is a potential problem with the AXIOM Artis or Artis zee system in connection with the hand switch operated at the patient table which may result in uncontrolled release of an x-ray image.
Distribution
US Nationwide Distribution.
Lot / Code Info
material number 3771750, model numbers: 5904441, 5904466, 7008605, 7412807, 7413078, 7555357, 7555365, 7555373, 7727717, 7728392, 10094135, 10094137, 10094139, 10094141, 10094142, 10094143, and 10280959
Root Cause
Device Design
Action Taken
Siemens sent an Important Safety Information letter dated June 5, 2014, to affected customers. The letter described the affected product, problem, and actions to be taken. Customers were instructed to observe this safety notice and comply with the corresponding measures until the update has been fully completed.