Micro-X Ltd. A14 6 MAB Eastern Promenade Tonsley Australia MICRO-X ROVER MOBILE X-RAY SYSTEM, MXU-RV19 Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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

Recommended Action

Per FDA guidance

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