Recall Z-1340-2020— Siemens Medical Solutions USA, Inc
Class II · Terminated
Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2020-01-24, terminated 2020-07-10. It names one FDA 510(k) clearance: K163286. Product: ARTIS Pheno-Interventional Fluoroscopic X-Ray System Model Number: 10849000 - Product Usage:AXIOM Artis is a family of 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 with the AXIOM Artis family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Axiom Artis can also support the acquisition of position triggered imaging for spatial data synthesis.. Reason: Potential exists for one or more axes of the robotic stand to become blocked by their safety brakes; In the event the axis is blocked by its safety brake, the robotic stand can no longer perform the intended movements.
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-01-24
- Terminated
- 2020-07-10
- Firm location
- Malvern, PA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
ARTIS Pheno-Interventional Fluoroscopic X-Ray System Model Number: 10849000 - Product Usage:AXIOM Artis is a family of 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 with the AXIOM Artis family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Axiom Artis can also support the acquisition of position triggered imaging for spatial data synthesis.
Reason for recall
Potential exists for one or more axes of the robotic stand to become blocked by their safety brakes; In the event the axis is blocked by its safety brake, the robotic stand can no longer perform the intended movements
Data sourced from openFDA. This site is unofficial and independent of the FDA.