Recall Z-1496-2021 ยท OWB Interventional Fluoroscopic X-Ray System
Siemens Medical Solutions USA, Inc
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. 059
| Date | Mar 30, 2021 |
| Status | Terminated |
| Reason | 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 | Equipment maintenance |
| Action | 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 attach |
| Quantity | 3,320 units U.S. |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |