—#165565

Product

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 product code: JAA — System, X-Ray, Fluoroscopic, Image-Intensified
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K021021
Affected lot / code info: Laird Cooling Unit for SSFD: Material # 7555118.

Why it was recalled

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

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 40 Liberty Blvd, Malvern, Pennsylvania 19355-1418

Distribution

Distribution pattern: HI , IL, MI, NC, NY, VA, WI

Timeline

Recall initiated: 2018-05-25
Terminated: 2019-05-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #165565. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.