Micro-X Rover Mobile X-Ray System, Mxu-Rv19 recallZ-1786-2022 · Micro-X Ltd. · initiated Aug 31, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Micro-X Ltd. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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
FDA root cause category: Process control
What the company is doing
On or about 09/31/2022, the firm sent an "URGENT: MEDICAL DEVICE CORRECTION" Letter via email/telephone to customers informing them that during an internal data analysis on 08/18/2022, Micro-X Ltd identified software calibration errors with the product equipped with a Dose Area Product (DAP) meter. This resulted in the product displaying incorrect DAP meter values. The DICOM image produced by the system will report a DAP measurement in microgray/square meter that is 8 to 10 times lower than the actual dose delivered. Customers are instructed to: 1. Inspect their stock immediately and place the Recall Notification Letter on the affected product and quarantine affected product on hand to prevent further use. 2. Contact the nominated Service representative to arrange the re-calibration of the DAP Meter. Email: [email protected] or Phone 1-206-249-8764. 3.Previous version of Service Documentation (ROV208-2 Acceptance and Compliance Testing Instructions) which includes inaccurate DAP calibration processes are to be removed from use. 4. Complete and return Acknowledgement and Receipt Form immediately to Micro-X LTD in Australia: [email protected] and copy [email protected] 5. Ensure relevant staff members are informed of the Recall and if affected units have been supplied/transferred to another facility, inform them immediately. For question or further assistance, contact Regulatory Affairs Manager at [email protected]
Recall details
- Recall number
- Z-1786-2022
- Status
- Open, Classified
- Initiated by the company
- Aug 31, 2022
- Posted by the FDA
- Sep 23, 2022
- Recalling firm
- Micro-X Ltd.
- Quantity
- 42 units
- Product code
- IZL
- FDA submissions
- K211423
- 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.
Product description
MICRO-X ROVER MOBILE X-RAY SYSTEM, MXU-RV19
Code information (models, lots, serial numbers)
Show the full code information (1k characters)
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
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Micro-X RoverMicro-X Limited · Solid State X-Ray Imager (Flat Panel/Digital Imager)2 recalls0 reports
Other devices under the same FDA submission
2 devices cleared under K211423 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Micro-X RoverMicro-X Limited · Solid State X-Ray Imager (Flat Panel/Digital Imager)7 recalls0 reports
- Micro-X RoverMicro-X Limited · Solid State X-Ray Imager (Flat Panel/Digital Imager)3 recalls0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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