Artis pheno- in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use-single and biplane diagnostic imaging and interventional procedures. Model: 10849000
Check against the official notice below — it lists the full affected range.
Siemens Medical Solutions USA, Inc. is recalling Artis pheno imaging systems used in combination with Siemens Healthineers or Trumpf/MAQUET tables due to five potential software issues. These issues affect the block movements function and manual rotation of the flat detector. Depending on the stage of a clinical intervention, the limited functionality resulting from these software errors may not be sufficient to continue treatment as planned, potentially causing clinical treatment delays until the system is restarted. The recall affects 20 units distributed nationwide, with specific serial numbers ranging from 164703 to 164763.
The source document does not specify a remedy for affected consumers.
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: 20 units Lot/code info: Serial Number: 164719 164712 164740 164722 164763 164735 164723 164743 164741 164728 164711 164718 164739 164703 164721 164726 164724 164725 164760 UDI: 04056869046877
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.