Reported Mar 7, 2018 · Terminated
Axiom Artis model Interventional fluoroscopic x-ray foot switch accessory; Model Numbers: 4787797, 4787805, and 4787813.
Siemens Medical Solutions USA, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Medical Solutions USA, Inc · 40 Liberty Blvd · Malvern, PA · 19355-1418
Is this the product you have?
- Axiom Artis model Interventional fluoroscopic x-ray foot switch accessory
- Model Numbers
47877974787805and 4787813
- Lot codes and dates
- Serial Numbers
142 of 142 codes
100061001010017100251004410050100511005510441078108115000150011501815021150321504415047150561505815060150761508815091151051511415116151311514415148151491700217004170071701117032170501706117062170741707817084171422000120002200052000920015200242003021004210062101721022210282103321039210472105221054
- Serial Numbers
- Amount recalled
- 142
This recall covers 9 products
The agency filed one notice per product. You are reading one of them; the other 8 are below.
Where it was sold
Why it was recalled
The possibility exists for the wireless foot switch to fail due to impacts by external factors, such as electrostatic discharge that exceed a certain intensity. If the foot switch fails, it will no longer be able to be used to release radiation. The hand switch provided can be used to release exposures; however, fluoroscopic examinations will not be possible.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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