Summary
The FDA issued a Class II for MICRO-X Rover Mobile X-ray System, # MXU-RV19 by Micro-X Ltd.. 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 land.
Details
Source
Device Recall
External ID
Z-0666-2025
Action Date
2024-12-18
Status
Ongoing
Category
device
Product Description
MICRO-X Rover Mobile X-ray System, # MXU-RV19
Lot/Code Info: 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, 333, 234, 266.
Quantity Affected: 23
Reason for Recall
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.
Distribution
US Nationwide Distribution: TX, CA, OH, ID, WA, AZ
Type: Voluntary: Firm initiated
Recall Initiated: 2024-10-23
Company
Tonsley
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 184 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Micro-X Ltd. has 10 FDA actions in our database, including 10 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Micro-X Ltd.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Micro-X Ltd. have FDA actions?
Micro-X Ltd. has 10 FDA actions in our database, including 10 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0666-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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