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
Class I - DangerousWhat Should You Do?
- Check if you have this product: (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
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Siemens Medical Solutions USA, Inc
- Reason for Recall:
- 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 I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
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
Product Codes/Lot Numbers:
(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
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1339-2022
Related Recalls
ARTIS Icono biplane, floor and ceiling.: ARTIS icono biplane Model 11327600. ARTIS icono ceiling Model 11328100. ARTIS icono floor Model 11327700. interventional fluoroscopic x-ray system
Siemens Medical Solutions USA
During patient examinations, the system may sporadically display a 0 x-ray dose administered to the patient. This behavior has only been observed during fluoroscopy and/or single-frame acquisitions. Despite the reported x-ray dose showing 0, an actual x-ray dose is applied to the patient.
ARTIS pheno, Model 10849000. interventional fluoroscopic x-ray system
Siemens Medical Solutions USA
During patient examinations, the system may sporadically display a 0 x-ray dose administered to the patient. This behavior has only been observed during fluoroscopy and/or single-frame acquisitions. Despite the reported x-ray dose showing 0, an actual x-ray dose is applied to the patient.
ARTIS Pheno VE30A and VE40A, Model 10849000
Siemens Medical Solutions USA
During 3D acquisitions, lighter and darker patient images may be captured, which may result in less accurate 3D reconstruction. The variation of brightness is a result of a constant unregulated medium dose and the angular change of patient diameter caused by rotational acquisition. This may result in unintentional low-dose radiation exposure to a patient.