Z-1470-2023 Class II Ongoing
FDA device recall Z-1470-2023 was initiated by FUJIFILM Healthcare Americas Corporation on February 27, 2023 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 77 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 3, 2023
- Initiation Date
- February 27, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 77 units
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.
Distribution Pattern
US Nationwide distribution.
Code Information
UDI: (01)04547410425505(11)200701. Serial numbers with the last 4 digits ending between ****0001 to ****1993.