Reported Jun 3, 2020 · Terminated
ARTIS Pheno - Interventional Fluoroscopic X-Ray System Model: 10849000 - Product Usage: 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
Is this the product you have?
- ARTIS Pheno - Interventional
- Fluoroscopic X-Ray System Model10849000 -
- Product Usageis 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
- Lot codes and dates
- Serial Numbers
105 of 105 codes
164011164013164018164019164021164022164024164025164026164027164028164033164034164048164049164053164054164055164057164060164061164063164064164066164068164069164071164072164073164074164075164080164083164084164086164088164094164095164097164098164100164105164113164115164121164124164125164132164134164138164140164142164152164153164155164157164158164159164160164161
- Serial Numbers
- Amount recalled
- 105 systems
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
If the C-arm leaves its intended travel path due to a fault within the drivetrain, movements may be impacted or impossible and the area of interest cannot be reached. In the event the C-arms movements are not possible, the system can only be returned to normal operation with the support of a field service engineer
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
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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