—#181459

Product

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 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: Serial 125253 103340 121526 121521 103335 109621 138311 148418 147237 109620 136555 121520 121525 121518 125254

Why it was recalled

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

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

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

Distribution

Distribution pattern: US Nationwide distribution.

Timeline

Recall initiated: 2020-04-30
Terminated: 2020-09-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #181459. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.