Micro-X Ltd.: MICRO-X ROVER MOBILE X-RAY SYSTEM, MXU-RV19

Recall number

Z-1786-2022

Recalling firm

Micro-X Ltd.

Product

MICRO-X ROVER MOBILE X-RAY SYSTEM, MXU-RV19

Status

Open, Classified

Initiated

2022-08-31

Posted

2022-09-23

Terminated

not on file

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

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: support-us@micro-x.com 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: support@micro-x.com and copy djerkovic@micro-x.com 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 djerkovic@micro-x.com

Quantity

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.

Lot, serial or model codes

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

510(k) numbers

["K211423"]

PMA numbers

not on file

Product code

IZL

Firm FEI

3012855798

Firm city

Tonsley

Firm state

not on file

Firm country

Australia

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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