FDA Medical devices recall ·
Rover Mobile X-ray System Model recall
- Recall number
- Z-1918-2026
- Date
- (initiated March 27, 2026)
- Company / brand
- Micro-X Ltd.
Unit 14 6 Mab Eastern Promenade, Tonsley, N/A, Australia - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 32 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Rover Mobile X-ray System Model/Catalog Number: MXU-RV35 and MXU-RV71
Why was it recalled?
X-Ray generator may malfunction resulting in the X-Ray being inoperable.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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
Distribution
US Nationwide distribution in the states and territories of WA, NJ, CA, Puerto Rico.
States: California New Jersey Puerto Rico Washington
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1918-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.