Recall Z-1150-2018— Siemens Medical Solutions USA, Inc
Class II · Terminated
Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2018-01-05, terminated 2018-08-23. It names one FDA 510(k) clearance: K021021. Product: AXIOM Artis angiographic x-ray system, Model Numbers: 7412807, 7413078, 7728392 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.. Reason: Certain systems may have leaking of the plastic coolant couplings, the liquid can enter into the flat panel detector leading to a failure of the detector. It may be necessary to cancel or restart the treatment or transfer the patient to an alternate or another system..
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-01-05
- Terminated
- 2018-08-23
- 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
AXIOM Artis angiographic x-ray system, Model Numbers: 7412807, 7413078, 7728392 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.
Reason for recall
Certain systems may have leaking of the plastic coolant couplings, the liquid can enter into the flat panel detector leading to a failure of the detector. It may be necessary to cancel or restart the treatment or transfer the patient to an alternate or another system.
Data sourced from openFDA. This site is unofficial and independent of the FDA.