Company: Tornier S.A.S. Date of Enforcement Report: 5/8/2025 Class II PRODUCT Blueprint Software, BPUE001. Intended for use by surgeons as a pre surgical planner for shoulder replacement. Recall Number: Z-1738-2025 REASON: A software bug in Blueprint version 4.2.1 prevents users from accessing cases initiated in previous versions of the software. RECALLING FIRM/MANUFACTURER: Tornier S.A.S. VOLUME:...Read More

Company: Philips Medical Systems Nederland B.V Date of Enforcement Report: 5/8/2025 Class II PRODUCT IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x; Model Number: 830089. Recall Number: Z-1740-2025 REASON: An issue was identified with the software when using the Echo Module of ISCV, the issue may result in missing or incomplete information in the report....Read More