Reported Jan 15, 2020 · Terminated
Cios Alpha, Model Number 10308191; mobile X-Ray system designed to provide X-ray imaging of the anatomical structures…
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 designed to provide X-ray imaging of the anatomical structures of patient during clinical application
- Lot codes and dates
- Serial Numbers
190 of 190 codes
112941120212009111411116311032113111126011258125301233411376124261133611132112951104411005113331138612597100761267710115112911252311056123191262312512125741264712014124521230612317111191257612678125131233512490126571120011281112831242512023123961128511205111031110511257110741237911013100211133011066
- Serial Numbers added as of 1/20/20
100781008911082110801124611380113791200612557127181273512732
- Serial Numbers
- Amount recalled
- 190 (updated total of 202 as of 1/20/20)
Where it was sold
Why it was recalled
During a routine inspection of a system, a crack on the C-arm holder was discovered. In the event the C-arm holder has a crack, the stability of the C-arm may be compromised and could lead to deformations of the C-arm. In very unlikely cases, an extreme impact to the C-arm such as heavy collision with a wall or table, may lead to a detachment of the C-arm and could potentially result in injury to patients and staff.
This product could cause temporary or reversible health problems — stop using it.
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