Z-1470-2023Class II

FujiFilm FDR AQRO (Model DR-XD1000)- A digital mobile X-ray system intended for use in general purpose...

Name: Z-1470-2023 FujiFilm FDR AQRO (Model DR-XD1000)- A digital mobile X-ray system intended for use in general purpose...
Creator: FUJIFILM Healthcare Americas Corporation
Published: 2023-02-27
License: https://open.fda.gov/license/

FUJIFILM Healthcare Americas Corporation / initiated 2023-02-27 / Open, Classified / root cause: design

FDA source

FUJIFILM Healthcare Americas Corporation began a recall of 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... on 2023-02-27. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1470-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-02-27
Posted: 2023-04-27
Recalling firm: FUJIFILM Healthcare Americas Corporation
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
Product code: IZL System, X-Ray, Mobile
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.
Root cause tag: design
FDA root cause: Device Design
Action: 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.
Quantity in commerce: 77 units
Distribution: US Nationwide distribution.
Product codes and lots: UDI: (01)04547410425505(11)200701. Serial numbers with the last 4 digits ending between ****0001 to ****1993.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1470-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1470-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-05-03	2023-04-27

Product code IZL

K170858Class IIFdr Aqro (Dr-Xd 1000)Fujifilm Medical Systems U.S.A, Inc. / cleared 2017-04-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)