FDA-Device2023-05-03Class II
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
FUJIFILM Healthcare Americas Corporation
Hazard
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.
Sold states
US Nationwide distribution.
Affected count
77 units
Manufactured in
81 Hartwell Ave Ste 300, N/A, Lexington, MA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1470-2023Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief