FUJIFILM Healthcare Americas Corporation FujiFilm 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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
FujiFilm 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
Brand
FUJIFILM Healthcare Americas Corporation
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
UDI: (01)04547410425505(11)200701. Serial numbers with the last 4 digits ending between ****0001 to ****1993.
FUJIFILM Healthcare Americas Corporation is recalling FujiFilm FDR AQRO (Model DR-XD1000)- A digital mobile X-ray system intended for use in general purpo due to 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 patie. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
FUJIFILM 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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026