Class II — FUJIFILM Healthcare Americas Corporation
| Recalling firm | FUJIFILM Healthcare Americas Corporation |
|---|---|
| Registered facility | FUJIFILM Healthcare Americas Corporation (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| 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. |
| 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 |
| Quantity | 77 units |
| Distribution | US Nationwide distribution. |
| Initiated | 2023-02-27 |
| Classified | 2023-04-27 |
| Recall number | Z-1470-2023 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — FUJIFILM Healthcare Americas Corporation (Z-1470-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/92012/
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