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U.S. Department of Health and Human Services

Class 2 Device Recall FDR AQRO (DRXD 1000)

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 Class 2 Device Recall FDR AQRO (DRXD 1000)see related information
Date Initiated by FirmFebruary 27, 2023
Date PostedApril 27, 2023
Recall Status1 Open3, Classified
Recall NumberZ-1470-2023
Recall Event ID 92012
510(K)NumberK170858 
Product Classification System, x-ray, mobile - Product Code IZL
ProductFujiFilm FDR AQRO (Model DR-XD1000)- A digital mobile X-ray system intended for use in general purpose radiography for generating radiographic images of human anatomy, including adult, pediatric, and neonatal exams
Code Information UDI: (01)04547410425505(11)200701. Serial numbers with the last 4 digits ending between ****0001 to ****1993.
FEI Number 1000513161
Recalling Firm/
Manufacturer		 FUJIFILM Healthcare Americas Corporation
81 Hartwell Ave Ste 300
Lexington MA 02421-3160
For Additional Information ContactSAME
617-861-5300
Manufacturer Reason
for Recall		Arm which holds the tube head in place is susceptible to breaking, if the device breaks it could potentially cause serious harm or injury to the patient and/or user.
FDA Determined
Cause 2		Device Design
ActionFUJIFILM Healthcare Americas Corporation (Fujifilm) issued Urgent Medical Device Recall letter on 2/27/23 via email to Distributors ad end-Users. Letter states reason for recall, health risk and action to take: A Fujifilm service engineer will contact your facility to arrange a visit to repair your affected unit(s). ACTIONS TO BE TAKEN BY THE CUSTOMER/END-USER 1)Perform an inspection according to the steps outlined below prior to using the product. a. If there are no abnormalities present during the pre-use inspection the product can continue to be used safely. b. Immediately remove the device from use if any abnormalities are observed and report the issueto your Fujifilm service engineer. 2)Coordinate with the Fujifilm service engineer to schedule the correction of your device whencontacted. 3)Please complete and return the Field Action Verification Form attached on page 6 of this communication. Responding with the information requested is essential for ensuring appropriate action is taken. Please contact our field action coordinator, Alicia Martinez, via phone at 973-459-9206 or email at alicia.martinez@fujifilm.com, if you have any further questions regarding this field action.
Quantity in Commerce77 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = IZL
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