Company: Micro-X Ltd. Date of Enforcement Report: 9/23/2022 ClassII PRODUCT MICRO-X ROVER MOBILE X-RAY SYSTEM, MXU-RV19 Recall Number: Z-1786-2022 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 RECALLING FIRM/MANUFACTURER Micro-X Ltd....Read More

Company: Cardiac Assist, Inc Date of Enforcement Report: 9/23/2022 Class I PRODUCT Devices Recall Number: Z-1763-2022 REASON Critical Failure of the LifeSPARC controller when the software freezes or crashes and the screen does not display data. RECALLING FIRM/MANUFACTURER Cardiac Assist, Inc VOLUME OF PRODUCT IN COMMERCE 723 units (484 currently in field) DISTRIBUTION US Nationwide...Read More