MICRO-X Rover Mobile X-ray System, # MXU-RV35
FDA device recall Z-0580-2025 · posted 2024-11-27 · Open, Classified
Recall details
- Recalling firm
- Micro-X Ltd.
- Reason for recall
- Mobile x-ray system receiving/storage(operation) requirements to be followed: Temp:14 to 131(50 to 86) degrees F, RH:10% to 86%(30% to 60%) allow condensation dry time, Atmospheric Pressure:50kPa to 106 kPa(70kPa to 106kPa), Altitude:-102ft to 12,000 ft, (Maximum Gradient:9 degrees Fahrenheit), which mitigate risk of capacitor malfunction, unpredictable behavior, overheating, unintended start-up.
- Action taken
- On 10/22/24, Service Bulletin SB007-23-1.0 was emailed to customers restating receiving, storage, and operation conditions and informing customers that extreme humidity environments can adversely affect the equipment. For further information contact your local service representative: phone: 1-206-249-8764 Email: support-us@micro-x.com
- Root cause
- Environmental control
- Status
- Open, Classified
- Product code
- IZL
- Quantity affected
- 6
- Distribution
- US: TX, PR, MD, CA
- Date initiated
- 2024-10-22
- Date posted
- 2024-11-27
- Location
- Tonsley, Australia
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Rover (K211423) | Micro-X Limited | 2021-05-21 |