R-30H , Diagnostic X-Ray Beam-Limiting Device. In combination with any of below X-ray tubes ...
FDA Recall #Z-0260-2013 — Class II — October 28, 2011
Product Description
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.
Reason for Recall
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.
Recalling Firm
Shimadzu Medical Systems — Torrance, CA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
665 units
Distribution
US Nationwide Distribution
Code Information
Device Model #R-30H
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated