Micro-X Ltd. Recall 90839
Description: MICRO-X ROVER MOBILE X-RAY SYSTEM, MXU-RV19
Micro-X Ltd. Recall 90839 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1786-2022 |
| Event ID | 90839 |
| Event Description | MICRO-X ROVER MOBILE X-RAY SYSTEM, MXU-RV19 |
| Product Type | Devices |
| Distribution | 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. |
| Quantity | 42 units |
| Recall Reason | 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 |
| Device Classification | 20221005 |
| Device Code Info | 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 |
| Center Classification Date | 20220923 |
| Recall Initiation Date | 20220831 |
| Recalling Firm | Micro-X Ltd. |
| Initial Notification | Letter |
| Similar To |