MICRO-X Rover Mobile X-ray System environmental operating requirements
Micro-X Ltd. is recalling 6 units of the MICRO-X Rover Mobile X-ray System due to environmental operating risks. The system requires strict temperature, humidity, and altitude controls to prevent capacitor malfunction, overheating, and unintended start-up.
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: This is an FDA Class II recall of a medical x-ray system with potential for capacitor malfunction, overheating, and unintended start-up if environmental operating parameters are not maintained. No illnesses or injuries have been reported; the hazards are theoretical and contingent on environmental non-compliance.
Plain-English summary
Micro-X Ltd. is recalling 6 units of the MICRO-X Rover Mobile X-ray System (Model MXU-RV35, Serial Numbers: 348, 349, 361, 351, 365, 391) distributed in the United States. The recall addresses environmental operating and storage requirements necessary to prevent capacitor malfunction, unpredictable behavior, overheating, and unintended start-up.
The system must be maintained within the following environmental parameters during operation: temperature between 50 and 86 degrees Fahrenheit, humidity between 30 and 60 percent, atmospheric pressure between 70 and 106 kPa, and altitude between -102 feet and 12,000 feet. Storage conditions allow broader tolerances: temperature between 14 and 131 degrees Fahrenheit and humidity up to 86 percent, with adequate time allowed for condensation to dry. A maximum temperature gradient of 9 degrees Fahrenheit should not be exceeded.
The affected units were distributed to medical facilities in Texas, Puerto Rico, Maryland, and California. If you operate one of these systems, verify that your facility's environmental conditions meet the specified parameters for safe operation. Contact Micro-X Ltd. or consult the device labeling for detailed compliance information and maintenance guidance.
The recalled product
- Product
- MICRO-X Rover Mobile X-ray System, # MXU-RV35
- Manufacturer
- Micro-X Ltd.
- Hazard
- capacitor-malfunction
- overheating
- unpredictable-behavior
- unintended-start-up
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 (7)
- UDI-DI: 9357123000037
- Serial Numbers: 348
- 349
- 361
- 351
- 365
- 391
Distribution
Distributed in 4 states:
- CA
- MD
- PR
- TX
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