Reported Nov 4, 2020 · Terminated
Siemens Artis one systems with a Display Port transceiver-Fluoroscopic X-Ray System Model: 10848600 - Product Usage: he…
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?
- Siemens Artis one systems with a Display Port transceiver-Fluoroscopic
- X-Ray System Model10848600 -
- Product Usagehe examination table as an integrated part of the system can be used for X-ray imaging, surgery and interventions. The Artis one can also support the acquisition of position triggered imaging for spatial data synthesis
- Lot codes and dates
- Serial Numbers
82010820388203982040820448205482065820668207082102821058210882109822058221382217822678230882354823558237882383
- Serial Numbers
- Amount recalled
- 22 units
Where it was sold
Why it was recalled
Potential malfunction in which the examination room monitor may become intermittently dysfunctional (e.g., no display/flicking/wrong resolution).
This product could cause temporary or reversible health problems — stop using it.
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