Recall archive / FDA device enforcement
syngo Application software VE20 (Material Number 10848815) installed on the Artis pheno and Artis icono systems as fo... — FDA record Z-1339-2022
Reported ongoing
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 Feb 25, 2022. 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
- syngo Application software VE20 (Material Number 10848815) installed on the Artis pheno and Artis icono systems as follows: (1) Artis pheno Model Number:10849000 (2) Artis icono biplane Model Number: 11327600 (3) Artis icono floor Model Number: 11327700
- Reason
- After CT image data from Toshiba is loaded, image mirroring can occur along the horizontal and vertical image axes. If this error occurs, the patient orientation/position may be misinterpreted and result in inappropriate treatment, even if the incorrect visualization is obvious.
- Classification
- Class II
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 127 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1339-2022
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 | (1)Artis Pheno UDI-DI: 04056869046877 (2)Artis icono biplane UDI-DI: 04056869063317 (3) Artis icono floor- UDI-DI: 04056869149325 S/N: Serial 170319 180062 180054 180019 164719 164712 180065 180056 180057 180041 180421 180317 180034 164740 180349 180301 164722 180367 180382 180060 164311 170026 180337 164763 180070 180048 180083 164735 180087 180370 180371 180372 180345 180315 170367 170368 164723 180343 180080 180305 180330 170331 164743 180379 180386 164741 180360 180333 170349 170361 180029 180352 180336 180407 164728 180412 180400 180397 180316 180068 180363 170334 170336 180084 180418 180334 164711 170025 180018 180350 180376 180354 180046 180047 180335 180085 164321 180035 164718 180339 180357 180358 180361 180362 180081 180423 170346 180331 180411 180381 180021 180342 170365 170322 180321 180309 180356 180378 180393 164739 180368 180413 180341 164703 180323 170303 170378 180329 180053 180055 164721 180043 170053 180049 180377 180077 180086 180015 180014 164726 164724 164725 180066 180082 164760 180037 180373 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US Nationwide.
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
- Jul 13, 2022
- Recall initiation date
- Feb 25, 2022
- Center classification date
- Jul 6, 2022
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.