Reported Jul 4, 2018 · Completed
ARTIS Pheno Interventional Fluoroscopic X-Ray System, Model 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 Interventional Fluoroscopic X-Ray System, Model 10849000
- Lot codes and dates
164033164071164034164095164057164055164054164080164072164088164048164094164068164019164013164073164027164026164025164060164083164021164066164075164084164086164074164098164028164053164063164064164024164049164022164018164100164097164011
- Amount recalled
- 39
This recall covers 13 products
The agency filed one notice per product. You are reading one of them; the other 12 are below.
Where it was sold
Why it was recalled
If the C-arm is manually moved in the longitudinal direction to a fully extended position, the system's safety stop mechanism may be activated. As a result, the C-arm stops the movement and can drop up to 20 mm (0.8 ). Under certain circumstances, the cover of the detector or collimator can touch and possibly injure the patient due to the C-arm drop. This could lead to a situation in which it is necessary to stop the clinical treatment or continue the treatment on an alternative system.
This product could cause temporary or reversible health problems — stop using it.
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