Reported Nov 14, 2012 · Terminated
0.7/1.3U163CS-36 In combination with below systems MobileArt Evolution, MobileDaRt Evolution Product Usage: The device…
Shimadzu Medical Systems
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 · 20101 S Vermont Ave · Torrance, CA · 90502-1328
Is this the product you have?
- 0.7/1.3U163CS-36 In combination with below systems MobileArt Evolution
- MobileDaRt Evolution Product UsageThe device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannot move and/or of outpatients in emergency
- Lot codes and dates
- S/N of X-ray tube
64510660366602666027718667064172470727407273573360733652XY0084531733727367973671739667424874258745467454874291745567483274834748337482974837760587632676069763557636476361763567635876363763672XY0080666806662XY00806502XY00803452XY00806492XY00806562XY00824532XY00824562XY00824612XY00827482XY00830392XY00754482XY00827502XY00830702XY00827782XY00830472XY00830582XY00836802XY00836272XY00836332XY00839512XY0084556
- S/N of X-ray tube
- Amount recalled
- 133 units
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
- Nationwide
Why it was recalled
Shimadzu is recalling Diagnostic X-ray Beam-Limiting Device, Mobile x-ray system and Diagnostic x-ray tube assembly because they do not comply with the Product Performance Standards, 21CFR 1020.30 (m) Beam quality --(1) Half-value layer (HVL), which was revised in 2006. Certain devices might not comply with the requirements for them in some x-ray generating condition after the revision in 2006.
This product could cause temporary or reversible health problems — stop using it.
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