Reported Nov 14, 2012 · Terminated
0.7/1.2JG326D-265 Product Usage: The device is a mobile X-ray system in order to take general radiography of patients…
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?
- 0.7/1.2JG326D-265
- 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
- MobileArt Evolution (12.5
- kW) S/N of X-ray tubeMobileArt
2XY00900492XY00900522XY00900622XY00903882XY00928242XY00928222XY00949442XY00949402XY00956282XY00959752XY00959962XY00975502XY00975392XY00000352XY0090058
- Evolution (32 kW) S/N of X-ray tube
2XY00928472XY00928512XY00928502XY00938932XY00938902XY00935612XY00968222XY00968282XY00975792XY00008342XY00010792XY00012152XY00012002XY00013112XY00012162XY00013122XY00012142XY00013772XY00013742XY00013832XY00014882XY00016532XY00014782XY00016572XY00016582XY00016742XY00016722XY00016442XY00020812XY00022812XY00020882XY00020832XY00022892XY0001827CM74B30120262XY00037742XY0004043
- Amount recalled
- 5 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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