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U.S. Department of Health and Human Services

Class 2 Device Recall R30H, Diagnostic Xray Beam Limiting Device

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 Class 2 Device Recall R30H, Diagnostic Xray Beam Limiting Devicesee related information
Date Initiated by FirmOctober 28, 2011
Date PostedNovember 08, 2012
Recall Status1 Terminated 3 on July 26, 2016
Recall NumberZ-0260-2013
Recall Event ID 62271
510(K)NumberK090578 
Product Classification Collimator, manual, radiographic - Product Code IZW
ProductR-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.
Code Information Device Model #R-30H
Recalling Firm/
Manufacturer		 Shimadzu Medical Systems
20101 S Vermont Ave
Torrance CA 90502-1328
For Additional Information Contact
310-217-8855 Ext. 139
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		Nonconforming Material/Component
ActionShimadzu 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 Commerce665 units
DistributionUS Nationwide Distribution
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = IZW
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