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Terminated

Multi Display Manager in the Artis Systems (Image-Intensified Fluoroscopic X-Ray System) as follows: Artis Q floor Model: 10848280; Artis Q ceiling Model: 10848281; Artis Q biplane Model:10848282; Artis zee ceiling Model: 10094137; Artis zee floor Model: 10094135 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.

FDA Recall Z-2302-2020 · Posted None

Recall StatusTerminated
Product CodeOWB
Date Initiated2020-04-30
Date Terminated2020-09-11
Product Quantity15 US

Reason for Recall

Artis systems containing a Multi Display Manager of a specific lot, the power distributor may lead to an increased electrical contact resistance or the interruption of electrical contact, and result in planned procedures to be terminated and performed on an alternative x-ray system

Firm Action

Siemens Healthineers issued Urgent Medical Device Correction via AX036/19/S, dated 4/30/20, letter states reason for recall, health risk, and action to take: Siemens will exchange the affected power distributor of the Multi Display Manager. We advise you not to move the Multi Display Manager Container or to open the power distributor before the corrective action can be completed. A service organization will contact you to schedule an appointment to perform the correction via Update Instruction AX035/19/S. Please feel free to contact service organization at 1-800-888-7436 for an earlier appointment. Following the correction, the cause will be eliminated, and any recurrence of this potential fault is prevented; Acknowledge Receipt of this Safety Advisory Notice, By signing this document, you are acknowledging that you have read and understand the content therein.

Root Cause

Nonconforming Material/Component

Distribution Pattern

US Nationwide distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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