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U.S. Department of Health and Human Services

Class 2 Device Recall BRANSIST safire

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  Class 2 Device Recall BRANSIST safire see related information
Date Initiated by Firm January 14, 2019
Create Date February 27, 2019
Recall Status1 Terminated 3 on June 07, 2024
Recall Number Z-0959-2019
Recall Event ID 81981
510(K)Number K062360  
Product Classification System, x-ray, angiographic - Product Code IZI
Product BRANSIST safire

Product Usage:
DIGITAL ANGIOGRAPHY SYSTEM This system is intended to be used for radiologic visualization of the heart, blood vessels or lymphatic system during or after injection of a contrast medium. It is to be used in the diagnosis of the circulatory vascular system while being combined with a positioning device and other devices.
Code Information Serial Numbers: 40AD58C4B001, 40AD58C55001, 0261Q80503, 0261Q80804, 0161Q84501, 0161Q83102, 3M7A16A1A001, 0161Q82302   
Recalling Firm/
Manufacturer		 Shimadzu Medical Systems Usa Com
20101 S Vermont Ave
Torrance CA 90502-1328
Manufacturer Reason
for Recall		 Normal operation of the device is to power up the device in the morning, register the first patient, and then perform a fluoroscopy. If, however, the user powers up the device in the morning and makes an error by starting a fluoroscopy while the first patient is still being registered, the device application will abnormally terminate and require service intervention before it can be used again. This event will not occur after the first patient procedure.
FDA Determined
Cause 2		 Software design
Action Shimadzu sent an Urgent Medical Device Correction Notice letter dated January 2, 2019 to affected customers. The letter identified the affected product, problem and actions to be taken. The letters to the end users explain the problem and a workaround. A service representative will contact the end user to schedule a software update.
Quantity in Commerce 8 units
Distribution US Nationwide Distribution in the states of IN, OH, IL, SC
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 CORP.
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