FDAFDA · Food and drugs·Recall number Z-0260-2013
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.
Published November 14, 2012 · Recall initiated: October 28, 2011
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Shimadzu Medical Systems
- Distributor
- US Nationwide Distribution
- Lot
- Device Model #R-30H
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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