Company: ExacTrac Dynamic (Medical Charged-Particle Radiation Therapy System). Date of Enforcement Report: 3/17/2021 Class II PRODUCT ExacTrac Dynamic (Medical Charged-Particle Radiation Therapy System). Recall Number: Z-1185-2021 REASON In case of a failed automatic marker detection, a software error causes parts of the display to incorrectly behave as if the current patient position is within predefined...Read More

Company: Thermo Fisher Scientific Date of Enforcement Report: 3/17/2021 Class II PRODUCT Cascadion SM Clinical Analyzer, REF 99990000 SN Type: 9910 Recall Number: Z-1202-2021 REASON Due to software defect, under certain assay parameters, false Vitamin D results may be reported. The system reports a false result by not quantitating the correct analyte peak in sample...Read More