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U.S. Department of Health and Human Services

Class 2 Device Recall Ultimax Digital Fluoroscopic XRay System

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 Class 2 Device Recall Ultimax Digital Fluoroscopic XRay Systemsee related information
Date Initiated by FirmMarch 15, 2017
Create DateAugust 30, 2017
Recall Status1 Terminated 3 on September 25, 2020
Recall NumberZ-3070-2017
Recall Event ID 77679
510(K)NumberK170832 
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
ProductToshiba America Medical Systems Ultimax Digital Fluoroscopic X-Ray System Model: DREX-UI80 Ultimax is intended for gastrointestinal studies, vascular studies, general radiography, and fluoroscopy. The system has medical applications ranging from but not limited to: contrast-enhanced studies, support of endoscopic studies, nonvascular contrast-enhanced studies, nonvascular IVR, vascular contrast-enhanced studies support of vascular NR, and general radiography.
Code Information Ser. No. U1A1692606
FEI Number 2020563
Recalling Firm/
Manufacturer		 Toshiba American Medical Systems Inc
PO Box 2068
2441 Michelle Dr
Tustin CA 92780-7047
For Additional Information Contact
714-730-5000
Manufacturer Reason
for Recall		The issue was identified as a firmware problem with the generator.
FDA Determined
Cause 2		Software design
ActionToshiba America Medical Systems ( TAMS) will bring the defect into Compliance: 1.You will issue a Customer Notification Letter to make customers aware of the hazards, what measures will be taken to remedy the defect at no cost to the user, and how to safely use the equipment before corrections can be made. 2.You will install modified firmware on the systems to correct the defect and prevent recurrence. 3.You will provide progress reports on the effectiveness of the plan. For further questions, please call (714) 730-5000.
Quantity in Commerce18
DistributionUS Distribution to the states of : LA, AR, IA, TX, IL, MN. MS, NJ, WV, SC, LA, WY, NC and CA.
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 = OWB
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