MICRO-X Rover Mobile X-ray System, # MXU-RV35; MICRO-X Rover Mobile X-ray System, # MXU-RV71
Summary
The FDA issued a Class II for MICRO-X Rover Mobile X-ray System, # MXU-RV35; MICRO-X Rover Mobile X-ray Syste by Micro-X Ltd.. Reason: Mobile x-ray system can report and deliver a lower post-exposure mAs value than what set by the operator..
Details
Source
Device Recall
External ID
Z-0665-2025
Action Date
2024-12-18
Status
Ongoing
Category
device
Product Description
MICRO-X Rover Mobile X-ray System, # MXU-RV35; MICRO-X Rover Mobile X-ray System, # MXU-RV71
Lot/Code Info: MXU-RV35 UDI-DI: 9357123000037 and MXU-RV71 UDI-DI: 935712300005 using Control Board PCBA, 12425-03 (or earlier). Serial Numbers: MSN00334, MSN00348, MSN00349, MSN00351, MSN00352, MSN00361, MSN00364, MSN00365,MSN00382, MSN00383, MSN00384, MSN00385, MSN00386, MSN00387, MSN00388, MSN00390, MSN00391, MSN00395
Quantity Affected: 18
Reason for Recall
Mobile x-ray system can report and deliver a lower post-exposure mAs value than what set by the operator.
Distribution
US Nationwide Distribution: NJ, CA, PR
Type: Voluntary: Firm initiated
Recall Initiated: 2023-11-28
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-0665-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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