MICRO-X Rover Medical X-ray System Hand Switch Activation Issue
Micro-X Ltd. is recalling 23 MICRO-X Rover Mobile X-ray Systems because the hand switch may be accidentally activated when dropped, causing the system to become unresponsive during patient imaging.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II device without reported illnesses or injuries. The hazard is a documented system malfunction during patient imaging that can disrupt care operations, meeting the criterion of risk-of-harm products where injury has not yet been reported.
Plain-English summary
Micro-X Ltd. is recalling 23 units of the MICRO-X Rover Mobile X-ray System, Model MXU-RV19. The affected units have serial numbers: 262, 274, 320, 329, 237, 269, 271, 290, 292, 307, 310, 311, 312, 321, 322, 323, 327, 330, 331, 332, 333, 234, and 266.
During internal testing, it was discovered that if the system is in a ready-to-expose state and the hand switch is dropped into the stowage unit, it may land on the prep/expose switch. This can briefly activate the prep switch, displaying an orange ring of death in the tube cooling area of the screen. When this occurs, the system becomes unresponsive to kV/mAs changes and prep/expose button presses, disrupting the imaging examination.
When this malfunction occurs, the only way to proceed is to suspend the patient, exit the Nexus DR software, and relogin to continue the examination. The recall affects units distributed in Texas, California, Ohio, Idaho, Washington, and Arizona.
The recalled product
- Product
- MICRO-X Rover Mobile X-ray System, # MXU-RV19
- Manufacturer
- Micro-X Ltd.
- Affected units
- 23
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- UDI-DI: 09357123000013. Serial Numbers: 262
- 274
- 320
- 329
- 237
- 269
- 271
- 290
- 292
- 307
- 310
- 311
- 312
- 321
- 322
- 323
- 327
- 330
- 331
- 332
Distribution
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