FDA recall Z-1786-2022

Product

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

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.

Key facts

Status

Ongoing

Initiation date

2022-08-31

Report date

2022-10-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Tonsley, N/A, Australia

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1786-2022