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U.S. Department of Health and Human Services

Class 2 Device Recall Fujifilm FDR Go PLUS

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 Class 2 Device Recall Fujifilm FDR Go PLUSsee related information
Date Initiated by FirmJanuary 15, 2019
Create DateMarch 21, 2019
Recall Status1 Terminated 3 on October 08, 2020
Recall NumberZ-1040-2019
Recall Event ID 82187
510(K)NumberK080701 
Product Classification System, x-ray, mobile - Product Code IZL
ProductFujifilm FDR Go PLUS, Mobile X-Ray System Product Usage: This device is intended to be used to take a film, CR or general radiography of patients in the hospital who cannot move and/or of outpatients in emergency. Exposure can be captured on film, CR or Digital Radiography (DR)>
Code Information Serial Numbers: MQ0001281001 through MQ0001285004
FEI Number 1000513161
Recalling Firm/
Manufacturer		 Fujifilm Medical Systems U.S.A., Inc.
81 Hartwell Ave Ste 300
Lexington MA 02421-3160
For Additional Information ContactJeffrey Wan
201-675-8947
Manufacturer Reason
for Recall		FUJIFILM Medical Systems U.S.A., Inc., Modality Systems became aware of the possibility that the braking mechanism might not be engaged in all cases when the driving handle has been released.
FDA Determined
Cause 2		Device Design
ActionFujifilm sent an Urgent Medical Device Correction and Removal letter dated January 16, 2019 to customers. The letter identified the affected product, problem and actions to be taken. Customers were advised to schedule a visit by our Service department to replace the handle assembly. Customers were provided with additional instructions to continue using the affected product safely until the correction was made. For questions call 201-675-8947.
Quantity in Commerce56 units
DistributionUS Nationwide Distribution
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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