—#162606

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.

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: Serial Numbers: 35061 35054 34999 35098 35059 35064 35073 35071 35057 35075 35083 35018 35097 35108 35046 35048 35050 46004 35045 35004 44011 35095

Why it was recalled

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.

Root cause (FDA determination)

Process control

Action the firm took

The firm, Siemens Healthineers, sent an "URGENT: MEDICAL DEVICE CORRECTION" letter dated 1/5/2018 to its consignees. The letter describes the product, problem and actions to be taken. The consignees were instructed to follow their standard emergency procedures in place in the event of system failures; to consider reinforcing these emergency procedures until the update has been completed. Siemens will replace all affected plastic couplings with metal couplings. The Siemens service organization will contact the consignees to arrange a date to perform this corrective action.If the device has been sold and is therefore no longer in your possession, please forward this field correction notice to the new owner. Our service organization will contact you shortly to arrange a date to perform this corrective action. Please feel free to contact our service organization for an earlier appointment at 1-800-888-7436.

Recalling firm

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

Distribution

Distribution pattern: US Distribution in the following U.S. states: AZ, CA, FL, IA, IL, LA, MI, NC, NJ, OH, OK, and TX.

Timeline

Recall initiated: 2018-01-05
Posted by FDA: 2018-03-20
Terminated: 2018-08-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #162606. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.