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
- Recall Initiated
- February 27, 2023
- Posted
- April 27, 2023
- Recall Number
- Z-1470-2023
- Quantity
- 77 units
- Firm Location
- Lexington, MA
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.
Distribution
US Nationwide distribution.
Lot / Code Info
UDI: (01)04547410425505(11)200701. Serial numbers with the last 4 digits ending between ****0001 to ****1993.
Root Cause
Device Design
Action Taken
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 alicia.martinez@fujifilm.com, if you have any further questions regarding this field action.