Device product
Rover Mobile X-ray System Model/Catalog Number: MXU-RV35 and MXU-RV71
Z-1918-2026
Product summary
- Firm
- Micro-X Ltd.
- Event
- Event 98644
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 32 units
- Official record key
device-enforcement:Z-1918-2026
Official wording
Reason: X-Ray generator may malfunction resulting in the X-Ray being inoperable.
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
Distribution pattern: US Nationwide distribution in the states and territories of WA, NJ, CA, Puerto Rico.
Derived failure modes
-
Unknown
X-Ray generator may malfunction resulting in the X-Ray being inoperable.