Device 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
Z-1470-2023
Product summary
- Event
- Event 92012
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 77 units
- Official record key
device-enforcement:Z-1470-2023
Official wording
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.
Code information: UDI: (01)04547410425505(11)200701. Serial numbers with the last 4 digits ending between ****0001 to ****1993.
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
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.