Artis zee/zeego, Angiographic x-ray system Stand alone system The Artis systems are a family of...
FDA Recall #Z-0971-2017 — Class II — December 8, 2016
Product Description
Artis zee/zeego, Angiographic x-ray system Stand alone system The Artis systems are a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Artis zee/ zeego and Q/ Q.zen include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Artis zee/ zeego and Q/ Q.zen can also support the acquisition of position triggered imaging for spatial data synthesis.
Reason for Recall
Siemens initiated a corrective action to address two possible, mutually independent causes of a system defect related to the following: - In Artis Systems with A100 Plus or A100G generators, an attempt to resume operation following detection of a fault can result in the failure of a module in the high-voltage generator. - For biplane systems delivered with software version VD11B since April of this year, software problems in conjunction with graphics card may, in rare cases, result in the loss of image display in the examination room.
Recalling Firm
Siemens Medical Solutions USA, Inc — Malvern, PA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
1,500 distributed Worldwide
Distribution
Nationwide Distribution
Code Information
Model # 10094135, 10094137, 10094139, 10094141, 10280959, 10848283
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated