Reported Aug 1, 2018 · Terminated
ARTIS Pheno, Fluoroscopic X-Ray system, Model Number 10849000
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, Fluoroscopic X-Ray system, Model Number 10849000
- Lot codes and dates
164033164071164034164095164057164054164055164080164072164088164048164094164068164019164013164073164025164026164027164060164083164021164066164075164074164084164086164098164028164053164063164064164024164049164018164022164061164100164097164011
- Amount recalled
- 40 in the United States
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
Why it was recalled
During manual LAO/RAO rotation at maximum speed or a combination of LAO/RAO and Cran/Caud rotation at maximum speed, the possibility exists for the safety monitoring within the system control to become activated. As a result, the C-arm stops the rotation and can drop up to 40 mm (1.6 ).
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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