Recall Z-1470-2023 ยท IZL System, X-Ray, Mobile
FUJIFILM Healthcare Americas Corporation
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
| Date | Apr 27, 2023 (initiated Feb 27, 2023) |
| Status | Open, Classified |
| 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. |
| Root cause | Device Design |
| Action | 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 |
| Quantity | 77 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K170858 | FDR AQRO (DR-XD 1000) Fujifilm Medical Systems U.S.A, Inc., Apr 24, 2017 |