Artis icono biplane -angiography systems developed for single and biplane diagnostic imaging and interventional procedures SMN: 11327600
Check against the official notice below — it lists the full affected range.
Siemens Medical Solutions USA, Inc. is recalling 51 units of Artis icono biplane angiography systems used for diagnostic imaging and interventional procedures distributed nationwide. The systems have a potential electrical safety hazard: if the protective earth connection is interrupted and an additional fault occurs, the system may fail to detect the resulting fault current. This could cause electric shock to a person in contact with metallic parts of the C-arm.
The affected units can be identified by the UDI-DI number 04056869063317 and specific serial numbers ranging from 180014 to 180336. The source document does not specify a remedy or required action for consumers who may have these devices.
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: 51 units Lot/code info: UDI-DI: 04056869063317 Serial Number: 180062 180054 180019 180065 180056 180057 180041 180317 180034 180072 180060 180070 180048 180083 180315 180080 180301 180305 180067 180330 180040 180333 180029 180336 180316 180084 180334 180018 180046 180047 180335 180085 180035 180081 180331 180021 180321 180309 180323 180329 180043 180049 180077 180086 180053 180055 180015 180014 180066 180082 180037
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.