Reported Aug 22, 2018 · Terminated
ARTIS Pheno Model 10849000. Interventional Fluoroscopic X-Ray System Product Usage: Artis is a family of dedicated…
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?
- ARTIS Pheno Model 10849000. Interventional
- Fluoroscopic X-Ray System Product UsageArtis is 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 family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Artis can also support the acquisition of position triggered imaging for spatial data synthesis
- Lot codes and dates
- Serial Numbers
164033164071164034164095164057164054164055164080164072164088164048164094164068164019164013164073164025164026164027164060164083164113164021164066164075164074164084164086164098164028164053164063164064164105164024164049164018164022164061164115164100164097164011
- Serial Numbers
- Amount recalled
- 605 units in total
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Potential hardware issue which may cause thermal effects and possible damage to system parts.
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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