Reported May 15, 2019 · Terminated
Cios Alpha, Model Number 10308191 Mobile X-ray system - Product Usage: The Cios Alpha is a mobile X-Ray system designed…
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?
- Cios Alpha, Model Number 10308191
- Mobile X-ray system - Product UsageThe Cios Alpha is a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications. Clinical applications may include but are not limited to interventional fluoroscopic, gastro-intestinal, endoscopic, urologic, pain management, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The patient population may include pediatric patients
- Lot codes and dates
- Serial Numbers
257 of 257 codes
112941120212006120091309813016128231301111163130091305912662110321131113007112581137911380125301233411376124261133611132112951300413121110441285911005113331138610076126771011511291110561128712319125291261712623126571287612886130481305013105131091311012848125741259712647130021287512810100781230612317
- Serial Numbers
- Amount recalled
- 257
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Continuous operation at very high tube output may result in increased wear of the radiation emitting components. This may occur when tube voltages of 125 kV are used for a long period, e.g. 30 minutes or more of continuous use. As a result, risk of premature failure of the Monoblock and loss of imaging X-rays.
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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