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U.S. Department of Health and Human Services

Class 2 Device Recall Fujifilm FDR Go Plus mobile Xray system

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 Class 2 Device Recall Fujifilm FDR Go Plus mobile Xray systemsee related information
Date Initiated by FirmJuly 19, 2019
Create DateAugust 30, 2019
Recall Status1 Terminated 3 on August 28, 2020
Recall NumberZ-2441-2019
Recall Event ID 83524
510(K)NumberK080701 
Product Classification System, x-ray, mobile - Product Code IZL
ProductFujifilm 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
For Additional Information ContactSAME
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
ActionFuji 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 Commerce174 units
DistributionNationwide
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 = IZL
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