United StatesThe affected product is the Rover Mobile X-ray System, Model/Catalog MXU-RV35 and MXU-RV71, distributed in the U.S. (including WA, NJ, CA and Puerto Rico); identifiers include UDI (01)09357123000051 for MXU-RV71 and UDI (01)09357123000037 for MXU-RV35 with the specific serial numbers listed in the notice. The systems were recalled because the X-ray generator may malfunction, resulting in the X-ray being inoperable.
What's being recalled
Rover Mobile X-ray System Model/Catalog Number: MXU-RV35 and MXU-RV71
Recalling firm: Micro-X Ltd., Tonsley, N/A, Australia.
How to identify it
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
The hazard
X-Ray generator may malfunction resulting in the X-Ray being inoperable.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US Nationwide distribution in the states and territories of WA, NJ, CA, Puerto Rico.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)