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FUJIFILM Healthcare Americas Corporation recalls FujiFilm FDR AQRO (Model DR-XD1000)- A digital mobile X-ray system intended for use in general purpose radiography for g
Recalled May 3, 2023 · FDA recall Z-1470-2023 · FUJIFILM Healthcare Americas
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. · FDA Class II
Units
77 units
Sold at
US Nationwide distribution.
Description
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.
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
Manufacturer(s)
FUJIFILM Healthcare Americas Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →