Z-0664-2025 Class II Ongoing
FDA device recall Z-0664-2025 was initiated by Micro-X Ltd. on May 31, 2023 and is designated Class II. Reason for recall: Shots were terminated by the mAs integrator; however, the 4 ms exposure time did not allow enough tolerance to achieve diagnostic exposures due to variations in hardware and how different timers are… The recall status is ongoing. Affected quantity: 5.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 18, 2024
- Initiation Date
- May 31, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5
Product Description
MICRO-X Rover Mobile X-ray System, # MXU-RV35
Reason for Recall
Shots were terminated by the mAs integrator; however, the 4 ms exposure time did not allow enough tolerance to achieve diagnostic exposures due to variations in hardware and how different timers are started.
Distribution Pattern
Worldwide and US Nationwide Distribution: NJ, PR, CA
Code Information
UDI-DI: 9357123000037. Serial Numbers: 00334, 00348, 00349, 00351, 00361.¿
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0664-2025
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026