—#186757

Product

Artis systems - Product Usage: an angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Model Numbers: System Material # AXIOM Artis FC 05904433; AXIOM Artis FA 05904441; AXIOM Artis MP 05904466; AXIOM Artis BC 05904649; AXIOM Artis BA 05904656; AXIOM Artis dBC Mag. Nav. 05917054; AXIOM Artis TA 07007755; AXIOM Artis dTA 07008605; AXIOM Artis dFC 07412807; AXIOM Artis dTC 07413078; AXIOM Artis dBA 07555357; AXIOM Artis dMP 07555365; AXIOM Artis dFA 07555373; AXIOM Artis dFC Mag. Nav. 07727717; AXIOM Artis TC 07728350; AXIOM Artis dBC 07728392; Artis zee floor 10094135; Artis zee ceiling 10094137; Artis zee MP 10094139; Artis zee biplane 10094141; Artis zee floor MN 10094142; Artis zee biplane MN 10094143; Artis Q floor 10848280; Artis Q ceiling 10848281; Artis Q biplane 10848282; Artis Q.zen floor 10848353; Artis Q.zen ceiling 10848354; Artis Q.zen biplane 10848355.

FDA product code: OWB — Interventional Fluoroscopic X-Ray System
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K052202, K181407
Affected lot / code info: All serial numbers

Why it was recalled

Due to inappropriate cleaning, some Artis systems show unexpected corrosion of visible belts which are needed to move system parts (e.g. C-Arm), Increased corrosion may lead to a malfunction of the belts which may result in limited functionality of the Artis system up to system failure. Unintended movement of the C-Arm may cause a hazardous situation to the patient, operator, or staff members and may result in a situation where it is necessary to cancel clinical treatment or to continue treatment on an alternative system

Root cause (FDA determination)

Equipment maintenance

Action the firm took

Siemens Medical Solutions USA, Inc. issued Urgent Medical Device Correction dated 3/303/21 (AX068/20/S). The letter states reason for recall, health risk and action to take: Use only recommended substances for cleaning and disinfection. Do not let cleaning liquids seep into the openings of the system, e.g., air openings, gaps between covers. Observe the attached cleaning and disinfection instructions. An addendum to the system Operator Manual explaining appropriate cleaning in detail has been released via Update Instruction AX068/20/S and is attached to this letter. This letter and the attached addendum should both be filed with the system documentation. Please feel free to contact our service organization at 1-800-888-7436 should you have any questions. The addendum will increase awareness concerning the cleaning process and mitigate the occurrence of the potential issue. There are no risks for patients who have previously been examined or treated. Acknowledge Receipt of this Safety Advisory Notice Please review, understand, and confirm acknowledgement of the information and instructions outlined in this Safety Advisory Notice. By signing this document, you are acknowledging that you have read and understand the content therein. Promptly notify and instruct accordingly all the staff at your organization who need to be aware of this notice and will comply with the recommendations therein. Please ensure that this safety advisory is retained in your product related records appropriately. In addition, if you may have further distributed this product, please identify your customers, and notify them at once of this product recall. If the device has been sold and is therefore no longer in your possession, please forward this notice to the new owner. We would also request you to inform us of the identity of the device's new owner where possible. Please forward this safety information to any other organizations that could be affected by this measure.

Recalling firm

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

Distribution

Distribution pattern: US Nationwide distribution.

Timeline

Recall initiated: 2021-03-30
Terminated: 2022-07-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #186757. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.