Artis icono biplane -angiography systems developed for single and biplane diagnostic imaging and interventional procedures SMN: 11327600
- Recall Initiated
- April 11, 2022
- Recall Number
- Z-1245-2022
- Quantity
- 51 units
- Firm Location
- Malvern, PA
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.
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
Root Cause
Device Design
Action Taken
Siemens Medical Solutions USA, Inc. has initiated a Customer Safety Advisory Notice to all affected customers via AX027/21/S on 4/11/22. Siemens will conduct an inspection of the protective earth via Update Instruction AX026/21/S. Our service organization will contact you shortly to arrange a date to perform this corrective action. Please feel free to contact our service organization for an earlier appointment at 1-800-888-7436. Acknowledge Receipt of this Safety Advisory Notice Please review, understand, and confirm acknowledgement of the information and instructions outlined in this Urgent Safety Advisory Notice. By signing this document, you are acknowledging that you have read and understand the content therein.