—#174027

Product

Artis zee multi, Model Number 10094139

FDA product code: OWB — Interventional Fluoroscopic X-Ray System
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K181407
Affected lot / code info: Serial Numbers: 157435 157509 157660 157710 157458 130017 157698 157532 157449 157657 157136 157690 157616 157560 157436 157677 157528 157503 157615 157448 157165 157700 157602 157168 157642 157213 157164 157559 157156 157524 157588 157750 157579 157573 157650 157671 157554 157555 157521 157696 157488 157644 157648 157169 157668 157508 157510 157601 157139 158058 157536 157625 157600 157604 157565 157634 157635 157146 157583 157476 157497 157570 157658 157505 157594 157706 157586 157674 157414 157215 157692 157707 157507 157708 157544 157184 157659 157661 157531 157409 157688 157702 157704 157466 157442 157667 157438 157440 157645

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 #174027. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.