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U.S. Department of Health and Human Services

Class 2 Device Recall R20J, Diagnostic Xray Beam Limiting Device

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 Class 2 Recall
R20J, Diagnostic Xray Beam Limiting Device
see related information
Date Posted November 08, 2012
Recall Status1 Open
Recall Number Z-0261-2013
Recall Event ID 62271
Premarket Notification
510(K) Number
K101036 
Product Classification Collimator, Manual, Radiographic - Product Code IZX
Product 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.
Code Information Device Model #R-20J
Recalling Firm/
Manufacturer
Shimadzu Medical Systems
20101 S Vermont Ave
Torrance, California 90502-1328
Consumer Instructions Contact the recalling firm for information
Manufacturer 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.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action Shimadzu sent an Urgent Voluntary Medical Device Recall - Field Safety Notice letters dated September 19, 2012 to all the affected customers. The letter identifed the description of non-compliance, how to identify the affected products, corrective action plan by Shimadzu and actions to be taken customers. Customers were instructed to contact their local Shimadzu representative or contact Shimadzu National Technical Support at Shimadzu Medical Systems National Technical Support (800) 228-1429.
Quantity in Commerce 308 units
Distribution US Nationwide Distribution
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = IZX and Original Applicant = SHIMADZU CORP.
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