—#193679

Product

Artis icono floor-angiography systems developed for single and biplane diagnostic imaging and interventional procedures SMN: 11327700

FDA product code: OWB — Interventional Fluoroscopic X-Ray System
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K190768, K193326
Affected lot / code info: UDI-DI: 04056869149325 Serial Number: 170026 170305 170307 170309 170310 170023 170304 170025 170051 170312 170027 170303 170053

Why it was recalled

if the protective earth is interrupted and an additional fault leads to a fault current, the detection of the fault current may not be ensured may cause an electric shock if a person is in contact with metallic parts of the Carm

Root cause (FDA determination)

Device Design

Action the firm took

Siemens Medical Solutions USA, Inc. has initiated a Customer Safety Advisory Notice to all affected customers via AX027/21/S on 4/11/22. Siemens will conduct an inspection of the protective earth via Update Instruction AX026/21/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. Acknowledge Receipt of this Safety Advisory Notice Please review, understand, and confirm acknowledgement of the information and instructions outlined in this Urgent Safety Advisory Notice. By signing this document, you are acknowledging that you have read and understand the content therein.

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: 2022-04-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #193679. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.