Z-1150-2018 Class II Terminated
FDA device recall Z-1150-2018 was initiated by Siemens Medical Solutions USA, Inc on Jan 5, 2018 and is designated Class II. 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… The recall status is terminated (terminated Aug 23, 2018). Affected quantity: 22.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 28, 2018
- Initiation Date
- Jan 5, 2018
- Termination Date
- Aug 23, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 22
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.
Distribution Pattern
US Distribution in the following U.S. states: AZ, CA, FL, IA, IL, LA, MI, NC, NJ, OH, OK, and TX.
Code Information
Serial Numbers: 35061 35054 34999 35098 35059 35064 35073 35071 35057 35075 35083 35018 35097 35108 35046 35048 35050 46004 35045 35004 44011 35095
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1150-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026