Recall Z-0580-2025 ยท IZL System, X-Ray, Mobile
Micro-X Ltd.
MICRO-X Rover Mobile X-ray System, # MXU-RV35
| Date | Nov 27, 2024 (initiated Oct 22, 2024) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Environmental control |
| Action | 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 |
| Quantity | 6 |
| Distribution | US: TX, PR, MD, CA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K211423 | Rover Micro-X Limited, May 21, 2021 |