Z-1918-2026 Class II Ongoing
FDA device recall Z-1918-2026 was initiated by Micro-X Ltd. on Mar 27, 2026 and is designated Class II. Reason for recall: X-Ray generator may malfunction resulting in the X-Ray being inoperable. The recall status is ongoing. Affected quantity: 32 units.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 29, 2026
- Initiation Date
- Mar 27, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 32 units
Product Description
Rover Mobile X-ray System Model/Catalog Number: MXU-RV35 and MXU-RV71
Reason for Recall
X-Ray generator may malfunction resulting in the X-Ray being inoperable.
Distribution Pattern
US Nationwide distribution in the states and territories of WA, NJ, CA, Puerto Rico.
Code Information
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1918-2026
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026