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U.S. Department of Health and Human Services

Class 2 Device Recall System, xray, mobile

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 Class 2 Recall
System, xray, mobile
see related information
Date Posted November 08, 2012
Recall Status1 Open
Recall Number Z-0265-2013
Recall Event ID 62271
Premarket Notification
510(K) Number
K080701 
Product Classification System, X-Ray, Mobile - Product Code IZL
Product 0.4/0.7JG326D-265AX/AT Product Usage: The device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannot move and/or of outpatients in emergency.
Code Information S/N of X-ray tube: 2XY0084725 2XY0084724 2XY0084723 2XY0099698 2XY0084726 2XY0084736 2XY0084739 2XY0084869 2XY0084729 2XY0084868 2XY0085162 2XY0085175 2XY0086383 2XY0086395 2XY0086726 2XY0086725 2XY0086724 2XY0087086 2XY0087088 2XY0087090 2XY0087421 2XY0087423 2XY0087427 2XY0087765 2XY0090747 2XY0091075 2XY0093894 2XY0096298 2XY0096820 2XY0096821 2XY0096832 2XY0096292 2XY0098245 2XY0098240 2XY0001064 2XY0001195 2XY0001088 2XY0001208 2XY0001077 2XY0001086 2XY0001198 2XY0001321 2XY0001204 2XY0001336 2XY0001337 2XY0001352 2XY0001388 2XY0001315 2XY0001370 2XY0001380 2XY0001464 2XY0001482 2XY0001484 2XY0001485 2XY0002730 2XY0003042 2XY0003037 2XY0003759 CM74B3016024 CM74B3017067 CM74B301201A CM74B3012018 CM74B3012017 CM74B301201C CM74B3012020 CM74B3012034 CM74B3012032 CM74B3013002 CM74B3016073 CM74B3016109 CM74B3015010
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 3 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 = IZL and Original Applicant = SHIMADZU CORP.
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