FDA DevicesClass II
Rover Mobile X-ray System Model/Catalog Number: MXU-RV35 and MXU-RV71
Published: April 29, 2026Recall ID: Z-1918-2026Category: devicesCountry: US
Reason for Recall / Hazard
X-Ray generator may malfunction resulting in the X-Ray being inoperable.
Product Description & Identification
Rover Mobile X-ray System Model/Catalog Number: MXU-RV35 and MXU-RV71
Affected Products
Rover Mobile X-ray System Model/Catalog Number: MXU-RV35 and MXU-RV71
Additional Source Details
| Field | Value |
|---|---|
| City | Tonsley |
| State | N/A |
| Event id | 98644 |
| Address 1 | Unit 14 6 Mab Eastern Promenade |
| Address 2 | N/A |
| 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 |
| Postal code | N/A |
| Report date | 20260429 |
| Product type | Devices |
| Product quantity | 32 units |
| Reason for recall | X-Ray generator may malfunction resulting in the X-Ray being inoperable. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260327 |
| Initial firm notification | |
| Center classification date | 20260422 |
Overview
- Recalling FirmMicro-X Ltd.
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide distribution in the states and territories of WA, NJ, CA, Puerto Rico.