Company: Philips North America Llc. Date of Enforcement Report: 9/18/2026 Class: II PRODUCT Achieva 1.5T, Achieva 1.5T Conversion and Achieva 1.5T Initial system; Model Numbers (REF): 1. 781196 (Achieva 1.5T), 2. 781343 (Achieva 1.5T), 3. 781283 (Achieva 1.5T Conversion), 4. 781346 (Achieva 1.5 Conversion), 5. 781178 (Achieva 1.5T Initial System); Recall Number: Z-3232-2026 REASON: A...Read More

Company: Philips Ultrasound, LLC Date of Enforcement Report: 9/18/2026 Class: II PRODUCT Philips EPIQ Elite Diagnostic Ultrasound System Model # 795234 Recall Number: Z-3249-2026 REASON: Due to software issue with ultrasound system, doppler sample is displayed shallower than its actual measurement location, potentially causing inaccurate blood flow velocity measurements and misdiagnosis. RECALLING FIRM/MANUFACTURER: Philips Ultrasound,...Read More