Artis icono floor in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use single and biplane diagnostic imaging and interventional procedures. Model: 11327700
Check against the official notice below — it lists the full affected range.
Siemens Medical Solutions USA, Inc. has recalled 35 Artis icono floor imaging systems (used in combination with Siemens Healthineers or Trumpf/MAQUET tables) that were distributed nationwide. The systems are affected by five potential software issues related to block movements and manual rotation of the flat detector, which could cause limited functionality during diagnostic imaging and intervention procedures.
Depending on the stage of a patient's treatment, these software errors may prevent the system from functioning adequately to continue treatment as planned, potentially resulting in delayed clinical treatment until the system is restarted. The recall affects units with specific serial numbers listed in the notification. 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: 35 units Lot/code info: S/N: Serial 170319 170026 170343 170367 170368 170305 170360 170307 170331 170349 170309 170310 170361 170351 170383 170023 170304 170328 170334 170336 170025 170346 170051 170358 170357 170333 170365 170332 170312 170027 170303 170378 170322 170053 170364 UDI: 04056869149325
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.