Recall archive / FDA device enforcement
Artis icono biplane with software VE20C-diagnostic imaging angiography system Model: 11327600 — FDA record Z-0516-2022
Reported terminated
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Oct 12, 2021. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Artis icono biplane with software VE20C-diagnostic imaging angiography system Model: 11327600
- Reason
- Four potential software issues with Artis pheno and Artis icono systems with software VE20C: 1. Updated calibration data not saved with measurement after scene+/-; 2. No x-ray possible, system shutdown/restart might be required during intervention; 3. Corrupted Image during Roadmap; 4. Unintended shutdown of Imaging System with UPS (Uninterruptable Power Supply) option
- Classification
- Class II
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 72 units
- Agency-reported status
- Terminated
- Source record identifier
- Z-0516-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Serial Numbers: 180062 180318 180054 180019 180065 180057 180041 180317 180034 180072 180349 180060 180337 180070 180048 180083 180369 180370 180345 180315 180343 180080 180301 180305 180067 180330 180040 180360 180333 180029 180352 180336 180316 180068 180363 180084 180334 180018 180350 180354 180046 180047 180335 180085 180035 180339 180357 180358 180361 180362 180081 180331 180021 180342 180321 180309 180356 180368 180341 180323 180329 180043 180049 180077 180086 180053 180055 180015 180014 180066 180082 180037 UDI: 04056869063317 Expanded Recall 12/20/21 S/N: 180056 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US Nationwide distribution.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Feb 2, 2022
- Recall initiation date
- Oct 12, 2021
- Center classification date
- Jan 21, 2022
- Termination date
- Apr 11, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.