Summary
The FDA issued a Class II for Rover Mobile X-ray System Model/Catalog Number: MXU-RV35 and MXU-RV71 by Micro-X Ltd.. Reason: X-Ray generator may malfunction resulting in the X-Ray being inoperable..
Details
Source
Device Recall
External ID
Z-1918-2026
Action Date
2026-04-29
Status
Ongoing
Category
device
Product Description
Rover Mobile X-ray System Model/Catalog Number: MXU-RV35 and MXU-RV71
Lot/Code Info: Lot Code: Refer to product traceability spreadsheet provided MXU-RV71 UDI: (01)09357123000051/ Serial Numbers: 334 397 399 408 423 425 459 MXU-RV35 UDI: (01)09357123000037/ Serial Numbers: 269 223 349 348 351 363 388 384 391 359 416 419 428 429 430 431 435 434 436 413 437 438 460 461 462
Quantity Affected: 32 units
Reason for Recall
X-Ray generator may malfunction resulting in the X-Ray being inoperable.
Distribution
US Nationwide distribution in the states and territories of WA, NJ, CA, Puerto Rico.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-03-27
Company
Tonsley, N/A
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 217 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-1918-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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