Z-1786-2022Class II

Micro-X Rover Mobile X-Ray System, Mxu-Rv19

Name: Z-1786-2022 Micro-X Rover Mobile X-Ray System, Mxu-Rv19
Creator: Micro-X Ltd.
Published: 2022-08-31
License: https://open.fda.gov/license/

Micro-X Ltd. / initiated 2022-08-31 / Open, Classified / root cause: manufacturing process

FDA source

Micro-X Ltd. began a recall of MICRO-X ROVER MOBILE X-RAY SYSTEM, MXU-RV19 on 2022-08-31. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1786-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-08-31
Posted: 2022-09-23
Recalling firm: Micro-X Ltd.
Product: Micro-X Rover Mobile X-Ray System, Mxu-Rv19
Product code: IZL System, X-Ray, Mobile
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
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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]
Quantity in commerce: 42 units
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 codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1786-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1786-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-10-05	2022-09-23

Product code IZL

K211423Class IIRoverMicro-X Limited / cleared 2021-05-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)