Z-1786-2022 Class II Ongoing
FDA device recall Z-1786-2022 was initiated by Micro-X Ltd. on August 31, 2022 and is designated Class II. Reason for recall: 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 managemen… The recall status is ongoing. Affected quantity: 42 units.
Recall Details
- Product Type
- Devices
- Report Date
- October 5, 2022
- Initiation Date
- August 31, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 42 units
Product Description
MICRO-X ROVER MOBILE X-RAY SYSTEM, MXU-RV19
Reason for Recall
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
Distribution Pattern
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.
Code Information
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