Artis icono biplane- in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use single and biplane diagnostic imaging and interventional procedures. Model: 11327600
Check against the official notice below — it lists the full affected range.
Siemens Medical Solutions USA, Inc. is recalling 94 Artis icono biplane imaging systems used in combination with Siemens Healthineers or Trumpf/MAQUET tables that were distributed nationwide. These systems contain five potential software issues related to the block movements function and manual rotation of the flat detector. Depending on the status of an ongoing intervention, these software errors may limit system functionality sufficiently to prevent treatment continuation as planned, potentially resulting in delayed clinical treatment that would require an additional system restart.
The affected systems are identified by specific serial numbers listed in the recall documentation. The source record does not specify a remedy or corrective action for consumers to take.
Written by software from the official notice below. Not reviewed by a lawyer.
Five potential software issues affecting Artis pheno and Artis icono systems in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). The potential software errors are related to the block movements function and manual rotation of the flat detector. Depending on the status of the intervention, the limited functionality may not be sufficient to continue with treatment as planned. This may result in a situation where clinical treatment may be delayed until an additional restart is performed
Reason for recall: Five potential software issues affecting Artis pheno and Artis icono systems in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). The potential software errors are related to the block movements function and manual rotation of the flat detector. Depending on the status of the intervention, the limited functionality may not be sufficient to continue with treatment as planned. This may result in a situation where clinical treatment may be delayed until an additional restart is performed Distribution: US Nationwide distribution. Quantity: 94 U.S. Lot/code info: S/N: 180062 180054 180019 180065 180056 180057 180041 180421 180317 180034 180072 180349 180367 180382 180060 180337 180070 180048 180083 180369 180370 180371 180372 180345 180315 180343 180080 180301 180305 180067 180330 180040 180379 180386 180360 180333 180029 180352 180336 180407 180412 180400 180397 180316 180068 180363 180084 180418 180334 180018 180350 180376 180354 180046 180047 180335 180085 180035 180339 180357 180358 180361 180362 180081 180423 180331 180411 180414 180381 180021 180342 180321 180309 180356 180378 180393 180368 180413 180341 180323 180329 180043 180049 180377 180077 180086 180053 180055 180015 180014 180066 180082 180037 180373 UDI: 04056869063317
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.