FUJIFILM Healthcare Americas Corporation: Medical Device Recall in 2023 - (Recall #: Z-1470-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: February 27, 2023

Date Posted: May 3, 2023

Recall Number: Z-1470-2023

Event ID: 92012

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.

Status: Ongoing

Product Quantity: 77 units

Code Information:

UDI: (01)04547410425505(11)200701. Serial numbers with the last 4 digits ending between ****0001 to ****1993.

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated