Artis icono floor-angiography systems developed for single and biplane diagnostic imaging and interventional procedures SMN: 11327700
Check against the official notice below — it lists the full affected range.
Siemens Medical Solutions USA, Inc. has recalled 13 Artis icono floor-angiography systems used for diagnostic imaging and interventional procedures. These systems were distributed nationwide and pose a potential electrical hazard: if the protective earth connection is interrupted and an additional fault occurs, the system may fail to detect the resulting fault current, which could cause electric shock to a person touching metallic parts of the C-arm.
The affected units can be identified by their UDI-DI number 04056869149325 and the following serial numbers: 170026, 170305, 170307, 170309, 170310, 170023, 170304, 170025, 170051, 170312, 170027, 170303, and 170053. The source does not specify a remedy or corrective action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
if the protective earth is interrupted and an additional fault leads to a fault current, the detection of the fault current may not be ensured may cause an electric shock if a person is in contact with metallic parts of the Carm
Reason for recall: if the protective earth is interrupted and an additional fault leads to a fault current, the detection of the fault current may not be ensured may cause an electric shock if a person is in contact with metallic parts of the Carm Distribution: US Nationwide distribution. Quantity: 13 units Lot/code info: UDI-DI: 04056869149325 Serial Number: 170026 170305 170307 170309 170310 170023 170304 170025 170051 170312 170027 170303 170053
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.