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.
FDA Recall Z-2525-2018 · Posted None
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Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeJAA
Date Initiated2018-05-25
Date Terminated2019-05-16
Product Quantity6 units US
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
Firm Action
Siemens issued on May 25, 2018 an URGENT: MEDICAL DEVICE CORRECTION customer notification to affected customers and advised a hardware update will be initiated . Users advised of the problem, potential risks and action to be taken. Siemens will correct the error by replacing all affected cooling units with Update Instruction AX076/17/S. Users may continue to use the Artis system while awaiting implementation of the corrective action.
Root Cause
Process control
Distribution Pattern
HI , IL, MI, NC, NY, VA, WI
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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