Siemens Medical Solutions USA, Inc Artis zee floor, Artis Q ceiling, Artis Q.zen ceiling. Image-Intensified Fluoroscopic X-Ray System. Material numbers 10848281, 10848354, 10094135, 10848354 - Product Usage: 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. Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Some electronic components within the generator were equipped with an incorrect protection diode. As a result, protection against overvoltage may be inadequate, and the system may not function properly in the event an overvoltage situation occurs.

Recommended Action

Per FDA guidance

On October 21, 2020, the firm notified customers via Urgent Medical Device Correction letter. The letter informed customers of the hardware error, and that customers could continue to use their system but needed to follow their standard emergency procedures they had in place in the event of system failures. It is recommended to consider reinforcing these emergency procedures until the update has been completed. Siemens advises that an alternative system is available to continue treatment in case of occurrence. Siemens is implementing a corrective action to all affected users via Update Instruction AX018/20/S. The Siemens Service organization will exchange the affected printed circuit boards of the generator. This modification will bring the voltage back to the center of the tolerance range. Siemens' service organization will contact you shortly to arrange a date to perform this corrective action. Please feel free to contact the 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.