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U.S. Department of Health and Human Services

Class 2 Device Recall Shimadzu Digital Radiography XRay System, DAR8000f

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  Class 2 Device Recall Shimadzu Digital Radiography XRay System, DAR8000f see related information
Date Initiated by Firm April 03, 2014
Date Posted May 08, 2014
Recall Status1 Terminated 3 on June 25, 2015
Recall Number Z-1569-2014
Recall Event ID 67927
510(K)Number K052500  
Product Classification System, x-ray, angiographic - Product Code IZI
Product Shimadzu Digital Radiography X-Ray System, Catalog No. DAR-8000f.

This device is intended to be used for radiography in the hospital with X-ray devices.
Code Information Serial Numbers: 0161G68101 0261G65303 0261G65702 0261G68204 3M72BFB21001 3M72BFB22004 3M72BFC2A001 3M72BFB32001 3M72BFB2A001 3M72BFC2C001 3M72BFB32006 3M72BFC33001 3M72BFB35005 3M72BFC34001
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 Corporation is recalling the Shimadzu Digital X-Ray System because they have received a report of a lost image under certain circumstances.
FDA Determined
Cause 2		 Software design
Action A Service Bulletin and a customer notification letter were sent on 4/3/2014 for all the customers who purchased the Shimadzu Digital X-Ray System (Catalog No. DAR-8000f). The notification informs the customers of the problems identified and the actions to be taken. Customers with questions or concerns about the device correction, are instructed to contact their local Shimadzu representative or contact Shimadzu National Technical Support at (800) 228-1429.
Quantity in Commerce 685 units total (14 units in US)
Distribution Worldwide Distribution-USA (nationwide) and the countries of Japan, China, Germany, Australia, Thailand, Sri Lanka, South Africa, UAE, Saudi Arabia, Korea, and Taiwan.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = IZI and Original Applicant = SHIMADZU MEDICAL SYSTEMS
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