Reported Jul 5, 2017 · Terminated
SHIMADZU FDR Visionary Catalog Number: FDR Visionary Suite Stationary x-ray system for taking general radiographic and…
Shimadzu Medical Systems USA Com
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: Shimadzu Medical Systems Usa Com · 20101 S Vermont Ave · Torrance, CA · 90502-1328
Is this the product you have?
- SHIMADZU FDR Visionary Catalog NumberFDR Visionary Suite Stationary x-ray system for taking general radiographic and tomographic images of the whole body. The device is intended to be used in hospitals, clinics, imaging centers, and/or other healthcare facilities by qualified/trained professionals
- Lot codes and dates
Serial No. 0162M4501 thru 0562M451033ZC5C2A0C002 thru 3ZC5C1734001D362M42902 thru 0562M4110141E733E69003MP95A8F5A001 thru MP95A9F6B001
- Amount recalled
- 1673 units total
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
Cracks may occur over time on the tube holding shaft near the base of the tube mounting flange.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
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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