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
Check against the official notice below — it lists the full affected range.
Siemens Medical Solutions USA is recalling syngo Application software VE20 installed on Artis pheno and Artis icono imaging systems. The software can cause CT image data from Toshiba to display mirrored along horizontal and vertical axes. When this mirroring occurs, the patient's orientation and position may be misinterpreted, potentially leading to inappropriate medical treatment, even when the incorrect image display is visually apparent.
A total of 127 units have been distributed nationwide. The affected systems are identified by specific serial numbers and UDI-DI codes for the Artis pheno, Artis icono biplane, and Artis icono floor models. The source document does not specify what actions affected consumers should take in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. Distribution: US Nationwide. Quantity: 127 units Lot/code info: (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 record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.