| Class 2 Device Recall Fujifilm FDR Go Plus mobile Xray system | |
Date Initiated by Firm | July 19, 2019 |
Create Date | August 30, 2019 |
Recall Status1 |
Terminated 3 on August 28, 2020 |
Recall Number | Z-2441-2019 |
Recall Event ID |
83524 |
510(K)Number | K080701 |
Product Classification |
System, x-ray, mobile - Product Code IZL
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Product | Fujifilm FDR Go Plus mobile X-ray system |
Code Information |
All serial numbers |
Recalling Firm/ Manufacturer |
Fujifilm Medical Systems U.S.A., Inc. 81 Hartwell Ave Ste 300 Lexington MA 02421-3160
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For Additional Information Contact | SAME 617-861-5300 |
Manufacturer Reason for Recall | The graphics driver of the FDR Go PLUS might cause the appearance of a Blue Screen of Death (BSoD) |
FDA Determined Cause 2 | Software design |
Action | Fuji Film issued notifications via FedEx standard overnight mail on July 19, 2019 advising of the problem, health risk and action to take: During this field action, you can continue to use your current FDR Go PLUS by following these additional instructions:1. Set the monitor sleep mode to Off. Complete the Field Action Verification Form, and upon receipt FUJIFILM service personnel will contact you to schedule a visit to correct your device.FUJIFILM will correct your affected device(s) by applying a registry file to your current software version, at no cost to you..
Question contact: Field action coordinator, Jeffrey Wan, via phone at 201-675-8947 or email mailto:jeffrey.wan@fujifilm.com |
Quantity in Commerce | 174 units |
Distribution | Nationwide |
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 = IZL
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