Z-0261-2013 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- November 14, 2012
- Initiation Date
- October 28, 2011
- Termination Date
- July 26, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 308 units
Product Description
R-20J , Diagnostic X-Ray Beam-Limiting Device. In combination with any of below X-Ray tubes: 06/1.2P364DK-85, 0.6/1.2P324DK-125, 06/1.2P324DK-85, 0.6/1.2P38DE-85. 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.
Distribution Pattern
US Nationwide Distribution
Code Information
Device Model #R-20J