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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 Posted November 08, 2012
Recall Status1 Open
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 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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