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Class 2 Device Recall Ultimax Digital Fluoroscopic XRay System |
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Date Initiated by Firm |
March 15, 2017 |
Create Date |
August 30, 2017 |
Recall Status1 |
Terminated 3 on September 25, 2020 |
Recall Number |
Z-3070-2017 |
Recall Event ID |
77679 |
510(K)Number |
K170832
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Product Classification |
Interventional fluoroscopic x-ray system - Product Code OWB
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Product |
Toshiba 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 |
Recalling Firm/ Manufacturer |
Toshiba American Medical Systems Inc PO Box 2068 2441 Michelle Dr Tustin CA 92780-7047
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For Additional Information Contact |
714-730-5000
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Manufacturer Reason for Recall |
The issue was identified as a firmware problem with the generator.
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FDA Determined Cause 2 |
Software design |
Action |
Toshiba 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 Commerce |
18 |
Distribution |
US Distribution to the states of : LA, AR, IA, TX, IL, MN. MS, NJ, WV, SC, LA, WY, NC and CA. |
Total Product Life Cycle |
TPLC Device Report
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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.
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510(K) Database |
510(K)s with Product Code = OWB and Original Applicant = Toshiba Medical Systems Corporation
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