Z-2525-2018 Class II Terminated
FDA device recall Z-2525-2018 was initiated by Siemens Medical Solutions USA, Inc on May 25, 2018 and is designated Class II. Reason for recall: Due to a defective sealing, coolant may inflow into the electrical parts of the system cabinet, which could cause a short circuit and cause the system to shut down suddenly during an ongoing procedure The recall status is terminated (terminated May 16, 2019). Affected quantity: 6 units US.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 1, 2018
- Initiation Date
- May 25, 2018
- Termination Date
- May 16, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6 units US
Product Description
AXIOM Artis with Laird Cooling Unit for SSFD: Material # 7555118. Artis is an angiography system developed for single and biplane diagnostic imaging and interventional procedures.
Reason for Recall
Due to a defective sealing, coolant may inflow into the electrical parts of the system cabinet, which could cause a short circuit and cause the system to shut down suddenly during an ongoing procedure
Distribution Pattern
HI , IL, MI, NC, NY, VA, WI
Code Information
Laird Cooling Unit for SSFD: Material # 7555118.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2525-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026