Recall Z-0666-2025 ยท IZL System, X-Ray, Mobile
Micro-X Ltd.
MICRO-X Rover Mobile X-ray System, # MXU-RV19
| Date | Dec 12, 2024 (initiated Oct 23, 2024) |
| Status | Open, Classified |
| Reason | During internal testing it was found that if the system is Ready to expose and the hand switch is then dropped into the stowage unit such that it lands on the prep/expose switch, the prep switch can be activated for a very short time such that the orange ring of death is displayed in the tube cooling area of the screen. The system then becomes unresponsive to kV/mAs changes, prep/expose presses. The only way to proceed is to suspend the patient, Exit Nexus DR and relogin and continue the exam. |
| Root cause | Device Design |
| Action | Starting on 10/23/24 Service Bulletin SB002-22 was sent to customers informing them that a field upgrade was released for the installation of an exposure switch holder. Customers were asked to complete and return an acknowledgement response form to support-us@micro-x.com For further information, contact your local service representative at support-us@micro-x.com, 1-206-249-8764. |
| Quantity | 23 |
| Distribution | US Nationwide Distribution: TX, CA, OH, ID, WA, AZ |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K211423 | Rover Micro-X Limited, May 21, 2021 |