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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 Device Recall System, xray, mobile see related information
Date Initiated by Firm October 28, 2011
Date Posted November 08, 2012
Recall Status1 Open3, Classified
Recall Number Z-0265-2013
Recall Event ID 62271
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 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
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 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = IZL and Original Applicant = SHIMADZU CORP.
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