—#183863

Product

Siemens Artis one systems with a Display Port transceiver-Fluoroscopic X-Ray System Model: 10848600 - Product Usage: he examination table as an integrated part of the system can be used for X-ray imaging, surgery and interventions. The Artis one can also support the acquisition of position triggered imaging for spatial data synthesis.

FDA product code: OWB — Interventional Fluoroscopic X-Ray System
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K133580
Affected lot / code info: Serial Numbers: 82010 82038 82039 82040 82044 82054 82065 82066 82070 82102 82105 82108 82109 82205 82213 82217 82267 82308 82354 82355 82378 82383

Why it was recalled

Potential malfunction in which the examination room monitor may become intermittently dysfunctional (e.g., no display/flicking/wrong resolution).

Root cause (FDA determination)

Component design/selection

Action the firm took

Siemens issued Urgent Medical Device Correction notification letter dated 9/22/20 via AX053/20/S stating reason for recall, health risk and action to take: Siemens will correct the error with a hardware replacement of the Display Port transceiver via Update Instruction AX052/20/S. 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. Please review, understand, and confirm acknowledgement of the information and instructions outlined in this Urgent Safety Advisory Notice. By signing this document.

Recalling firm

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

Distribution

Distribution pattern: US Nationwide distribution including in the states of AL, AR, AZ, CA, FL, IN, LA, MI, MO, NC, NJ, NY, PA, TX, WA.

Timeline

Recall initiated: 2020-09-21
Terminated: 2021-08-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #183863. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.