FDA Recall Open, Classified

Artis icono floor-angiography systems developed for single and biplane diagnostic imaging and interventional procedures SMN: 11327700

Recall: Z-1246-2022 · Initiated April 11, 2022

Recall

Recall Number
Z-1246-2022
Event Number
90184
Firm
Siemens Medical Solutions USA, Inc
FEI Number
2240869
Product Code
OWB
Status
Open, Classified
Root Cause
Device Design
Initiated
April 11, 2022
Address
40 Liberty Blvd, Malvern, PA, 19355-1418

Description

Artis icono floor-angiography systems developed for single and biplane diagnostic imaging and interventional procedures SMN: 11327700

Reason

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

Action

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.

Distribution

US Nationwide distribution.

Quantity

13 units