Home / Recalls / Medical Devices
Shimadzu Medical Systems recalls R-30H , Diagnostic X-Ray Beam-Limiting Device. In combination with any of below X-ray tubes 0.6/1.2P364DK-85, 0.6/
Recalled November 14, 2012 · FDA recall Z-0260-2013 · Shimadzu Medical Systems
Hazard
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. · FDA Class II
Units
665 units
Sold at
US Nationwide Distribution
Description
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.
Product
R-30H , Diagnostic X-Ray Beam-Limiting Device. In combination with any of below X-ray tubes 0.6/1.2P364DK-85, 0.6/1.2P324DK-125, 0.6/1.2P324DK-85, 0.6/1.2P38DE-85 Device Model # R-30H. Subsequent Product Code: IZX Product Usage: The device is the beam-limiting device for X-ray Radiography.
Manufacturer(s)
Shimadzu Medical Systems
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →