—#153989

Product

ARTIS Q, Interventional Fluroscopic x-ray system

FDA product code: OWB — Interventional Fluoroscopic X-Ray System
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K123529
Affected lot / code info: Model # 10848280, 10848281, 10848282, 10848283, 10848353, 10848354, 10848355 Serial # 109033 117012 121061 109080 109074 121006 121013 121040 105007 111005 109016 121062 111002 121082 121011 121039 123008 109066 109067 109068 121053 121054 117001 117023 123003 123011 109084 121014 121051 109011 121004 117021 121018 121036 123013 123014 117029 117006 121012 121049 103013 109015 121019 109057 121010 117034 103008 109038 109040 109034 117020 109029 111003 121015 109064 109009 117018 117030 109058 121016 109050 109076 117026 123022 109007 103001 111000 109071 109072 109075 121020 109090 109041 109039 109060 121047 123023 123024 117024 109088 121027 121069 109032 121009 121056 121057 109021 121034 121008 109048 109020 109036 109043 121058 109047 109031 109027 109028 109010 121071 109069 117014 123010 117009 121023 123015 123016 121041 109044 121037 121046 121072

Why it was recalled

In Artis systems with A100G generators, a component can be affected by aging which could result in the potential failure of a module in the high-voltage generator.

Root cause (FDA determination)

Other

Action the firm took

A Customer Safety Advisory Notice (CSAN) was mailed on 02/22/2017 to customers affected by the issue on 02/22/2017 to inform them of the corrective action they plan to perform to prevent a possible hazard to persons and equipment. The notice explained the underlying issue, the impact on system operation and the potential risk to patients. It also informed users of the actions being taken and how they will be implemented.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 40 Liberty Blvd, Malvern, Pennsylvania 19355-1418

Distribution

Distribution pattern: Distributed throughout the United States.

Timeline

Recall initiated: 2017-02-22
Posted by FDA: 2017-03-19
Terminated: 2017-10-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #153989. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.