Reported May 13, 2015 · Terminated
AXIOM ARISTOS FX; Multipurpose Radiography System (MPRS) is a dedicated x-ray system with a flat panel detector which…
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 · 51 Valley Stream Pkwy · Malvern, PA · 19355-1406
Is this the product you have?
- AXIOM ARISTOS FX; Multipurpose Radiography System (MPRS) is a dedicated x-ray system with a flat panel detector which allows the acquisition of x-ray exposures without the use of conventional film/screen systems. The MPRS allows radiographic exposures of the whole body including skull, spinal column, chest, abdomen, extremities, and excluding mammography. Radiographic exposures may be taken with the patient in the sitting, standing, or supine positions. The intended use and indications for use of this modified device as described in its labeling have not changed from its predicate device.
- Lot codes and dates
- Model Number of device7414803, Serial #s:
1008112110161156115710561043112610761137108810931030103310291032110011241139105010581078112710401035115511431074110911351007113111101081106411451146114710591122114010031083
- Model Number of device7414803, Serial #s:
- Amount recalled
- 43
Where it was sold
- Nationwide
Why it was recalled
If the cable cart and the corrugated hose are unable to move freely, the cable holder could drop down and hit patients or system operators.
This product could cause temporary or reversible health problems — stop using it.
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