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U.S. Department of Health and Human Services

Class 2 Device Recall Sonialvision Safire II, Model : DAR8000f

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 Class 2 Device Recall Sonialvision Safire II, Model : DAR8000fsee related information
Date Initiated by FirmJanuary 12, 2018
Create DateJune 14, 2018
Recall Status1 Terminated 3 on February 24, 2022
Recall NumberZ-2060-2018
Recall Event ID 80067
510(K)NumberK052500 
Product Classification System, x-ray, angiographic - Product Code IZI
ProductSonialvision Safire II, Model #: DAR-8000f Product Usage: This angiographic x-ray system device intended to be used for the radiography in the hospital with X-ray devices. This device is operated and used by the physicians and X-ray technologist. The object of this device is total patient population.
Code Information Serial #: 0161G68101, 0261G65303, 0261G65702, 0261G68204, 3M72BFB21001, 3M72BFB2A001, 3M72BFC2A001, 3M72BFC2C001, 3M72BFB32001, 3M72BFB32006, 3M72BFB33003,3M72BFC33001, 3M72BFC34001, 3M72BFB35005, 3M72BFC37002, 3M72BFC42001, 3M72BFB46002  
FEI Number 1000125362
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		When selecting serial radiography with a pulse rate of 7.5fps (including selecting a preset or changing the pulse rate using a temporary edit function) it was observed the indicated "irradiation time" on the X-ray Generator Console, as well as the "integral dose" on the external console of fluoroscopy, were reset to 0. There has been one report of this event.
FDA Determined
Cause 2		Software design
ActionShimadf0u sent an Urgent Voluntary Medical Device Recall Notice letter dated January 2018. The letter identified the affected product, problem and actions to be taken. For questions contact Shimadzu representative or contact Shimadzu National Technical Support at 800-228-1429.
Quantity in Commerce17
DistributionUS Nationwide in the states of IL, WA, MI, TX, AZ, CA, LA, FL, SC, and NJ.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = IZI
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