FujiFilm FDR AQRO (Model DR-XD1000)- A digital mobile X-ray… recallZ-1470-2023 · FUJIFILM Healthcare Americas Corporation · initiated Feb 27, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from FUJIFILM Healthcare Americas Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Device Design
What the company is doing
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 [email protected], if you have any further questions regarding this field action.
Recall details
- Recall number
- Z-1470-2023
- Status
- Open, Classified
- Initiated by the company
- Feb 27, 2023
- Posted by the FDA
- Apr 27, 2023
- Recalling firm
- FUJIFILM Healthcare Americas Corporation
- Quantity
- 77 units
- Product code
- IZL
- FDA submissions
- K170858
- Distribution
- US Nationwide distribution.
Product description
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
Code information (models, lots, serial numbers)
UDI: (01)04547410425505(11)200701. Serial numbers with the last 4 digits ending between ****0001 to ****1993.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- FDR AQRO DR-XD 1000Fujifilm Corporation · System, x-ray, mobile1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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