Recall Z-1470-2023— FUJIFILM Healthcare Americas Corporation

Name: FDA recall Z-1470-2023
Creator: U.S. Food and Drug Administration
Published: 2023-02-27

Class II · Ongoing

Class II FDA medical device recall by FUJIFILM Healthcare Americas Corporation, initiated 2023-02-27. It names one FDA 510(k) clearance: K170858. 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. Reason: 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..

Recalling firm: FUJIFILM Healthcare Americas Corporation
Classification: Class II
Status: Ongoing
Initiated: 2023-02-27
Firm location: Lexington, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K170858 — FDR AQRO (DR-XD 1000)Fujifilm Medical Systems U.S.A, Inc.·cleared 2017-04-24

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.