Company: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Date of Enforcement Report: 1/16/2026 Class: II PRODUCT: Philips Azurion system; Software Version Number: R3.1; Recall Number: Z-1113-2026 REASON: Philips has identified two (2) software issues affecting device systems that may result in loss of imaging (X-ray) functionality and/or loss of motorized movement, and/or incorrect image content and/or loss...Read More

Company: CHANGE HEALTHCARE CANADA COMPANY Date of Enforcement Report: 10/14/2020 Class II PRODUCT Change Healthcare Radiology Solutions 14.0 Recall Number: Z-0072-2021 REASON Software defect which may potentially result in one or more images missing in a study. RECALLING FIRM/MANUFACTURER CHANGE HEALTHCARE CANADA COMPANY on 8/25/2020. Voluntary:  Firm Initiated recall is ongoing. VOLUME OF PRODUCT IN...Read More

FDA has issued a final order to reclassify: medical image analyzers applied to mammography breast cancer ultrasound breast lesions radiograph lung nodules radiograph dental caries detection all which are post-amendments class III devices (regulated under product code MYN), into class II (special controls), subject to premarket notification. These devices are intended to direct the clinician’s...Read More