Reported Aug 12, 2015 · Terminated
Axiom Artis systems, dedicated angiography systems developed for single and biplane diagnostic imaging and…
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 · 51 Valley Stream Pkwy · Malvern, PA · 19355-1406
Is this the product you have?
- Axiom Artis systems, 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 include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures.
- Lot codes and dates
- Model Number of device
77277177555357772839259170547555373741280770086057413078700775577283505904649590443359046565904441
- serial numbers
1,215 of 1,215 codes
281511410135143352393770146017460224602353181400235516355057281004007244151531045306728021400753209932101354561037310407103261409546154461075515728108441013532753093252093536844246460714607225267500633543235690441855530410328281195316230002353013545135553462632528025163553993542735743357503576240012
- Model Number of device
- Amount recalled
- N/A
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
The possibility exists for a large amount of liquid to seep through the top cover of the table and penetrate the components inside the table. If this occurs, table movements may no longer be possible. No injuries reported.
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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