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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-0264-2013
Recall Event ID 62271
510(K)Number K090268 
Product Classification System, x-ray, mobile - Product Code IZL
Product 0.7/1.2JG326D-265


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 MobileArt Evolution (12.5 kW) S/N of X-ray tube:
2XY0090049
2XY0090052
2XY0090062
2XY0090388
2XY0092824
2XY0092822
2XY0094944
2XY0094940
2XY0095628
2XY0095975
2XY0095996
2XY0097550
2XY0097539
2XY0000035
2XY0090058

MobileArt Evolution (32 kW) S/N of X-ray tube:
2XY0092847
2XY0092851
2XY0092850
2XY0093893
2XY0093890
2XY0093561
2XY0096822
2XY0096828
2XY0097579
2XY0000834
2XY0001079
2XY0001215
2XY0001200
2XY0001311
2XY0001216
2XY0001312
2XY0001214
2XY0001377
2XY0001374
2XY0001383
2XY0001488
2XY0001653
2XY0001478
2XY0001657
2XY0001658
2XY0001674
2XY0001672
2XY0001644
2XY0002081
2XY0002281
2XY0002088
2XY0002083
2XY0002289
2XY0001827
CM74B3012026
2XY0003774
2XY0004043
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 5 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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