FDAFDA · Food and drugs·Recall number Z-1786-2022
MICRO-X ROVER MOBILE X-RAY SYSTEM, MXU-RV19
Published October 5, 2022 · Recall initiated: August 31, 2022
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Software calibration error with product equip with a Dose Area Product (DAP) meter. This results in the product displaying the incorrect DAP meter values which may impede radiation exposure management decisions
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Micro-X Ltd.
- Distributor
- Worldwide distribution - U.S. Nationwide distribution in the states of CA, NV, NY, OH, TX and WA and the countries of Australia, France, Israel, Japan, and United Arab Emirates.
- Lot
- Model Number: MXU-RV19 UDI Codes: (01)09357123000013(11)210326(21)00222 (01)09357123000013(11)210628(21)00234 (01)09357123000013(11)210629(21)00235 (01)09357123000013(11)210629(21)00236 (01)09357123000013(11)210630(21)00237 (01)09357123000013(11)210708(21)00238 (01)09357123000013(11)210721(21)00240 (01)09357123000013(11)210910(21)00261 (01)09357123000013(11)210913(21)00262 (01)09357123000013(11)210914(21)00263 (01)09357123000013(11)210921(21)00264 (01)09357123000013(11)210922(21)00265 (01)09357123000013(11)210923(21)00266 (01)09357123000013(11)210927(21)00267 (01)09357123000013(11)211006(21)00268 (01)09357123000013(11)211008(21)00269 (01)09357123000013(11)211011(21)00270 (01)09357123000013(11)211011(21)00271 (01)09357123000013(11)211012(21)00272 (01)09357123000013(11)211013(21)00273 (01)09357123000013(11)211013(21)00274 (01)09357123000013(11)211210(21)00288 (01)09357123000013(11)211213(21)00289 (01)09357123000013(11)211213(21)00290 (01)09357123000013(11)220329(21)00305 (01)09357123000013(11)220330(21)00306 (01)09357123000013(11)220331(21)00307 (01)09357123000013(11)220401(21)00308 (01)09357123000013(11)220404(21)00309 (01)09357123000013(11)220405(21)00310 (01)09357123000013(11)220406(21)00311 (01)09357123000013(11)220404(21)00312 Serial Numbers: 222 234 235 236 237 238 240 261 262 263 264 265 266 267 268 269 270 271 272 273 274 288 289 290 305 306 307 308 309 310 311 312
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Australia
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