—#174019

Product

AXIOM Artis dMP, Model Number 7555365

FDA product code: OWB — Interventional Fluoroscopic X-Ray System
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K052202
Affected lot / code info: Serial Numbers: 57204 57089 57077 57024 57144 57189 57208 57035 57188 57073 57072 57016 57009 57050 57207 57111 57171 57113 57193 57008 57198 57155 57124 57004 57105 57098 57116 57045 57156 58701 57183 57187

Why it was recalled

A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible. The issue occurs sporadically; however, it may occur during an on-going procedure.

Root cause (FDA determination)

Component design/selection

Action the firm took

Urgent Medical Device Correction notification letters dated 6/12/19 were sent to customers. In the event the issue occurs, the system cannot be operated normally as X-ray will not possible. Planned procedures may have to be terminated and performed on an alternative X-ray system. Siemens advises that an alternative system is available to continue treatment in case of occurrence. Siemens is implementing a corrective action to all potentially affected users of the Artis Zee and AXIOM Artis systems with generator A100 via Update Instruction AX038/18/S. The Siemens Service organization will modify the affected supply circuit and revise the wiring. This modification will bring the voltage back to the center of the tolerance range. 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. Following the correction, the cause is eliminated and any recurrence of this potential fault is prevented.

Recalling firm

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

Distribution

Distribution pattern: US Nationwide Distribution

Timeline

Recall initiated: 2019-06-12
Terminated: 2020-09-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #174019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.