Company: Philips Medical Systems Nederland B.V. Date of Enforcement Report: 6/12/2025 Class: II PRODUCT Azurion R1.x and R2.x systems; Model Numbers: (1) 722063, (2) 722064, (3) 722067, (4) 722068, (5) 722078, (6) 722079, (7) 722221, (8) 722222, (9) 722223, (10) 722224, (11) 722225, (12) 722226, (13) 722227, (14) 722228, (15) 722280, (16) 722281, (17) 722282;...Read More

Company: Turncare, Inc Date of Enforcement Report: 6/12/2025 Class: II PRODUCT Brand Name: Guardian 2 System Product Name: Guardian System 2 Controller Model/Catalog Number: GS-2.5-C Software Version: 2.5.4-59 (Fix) Recall Number: Z-1967-2025 REASON: A software issue where “low” and “terminal” battery alerts did not display on the screen to the user in specific circumstances when...Read More

Company: Mobius Mobility LLC Date of Enforcement Report: 6/12/2025 Class: II PRODUCT iBOT PMD with software version 01.05.24. Personal Mobility Device. Recall Number: Z-1965-2025 REASON: Software issue that could potentially lead to the device tipping over from Balance Mode. RECALLING FIRM/MANUFACTURER: Mobius Mobility LLC VOLUME: 442 units DISTRIBUTION: US Nationwide distribution in the states of...Read More