Company: RAYSEARCH LABORATORIES AB Date of Enforcement Report: 08/25/2023 Class II PRODUCT RayCare software, include version number 5A, 5B, 6A, including service packs-An oncology information system used to support workflows and scheduling, as well as clinical information, planning and treatment management for oncology care. Model Numbers: 5.0.0, 5.0.1, 5.1.1,5.1.2, 5.1.3, 6.0.0 Recall Number: Z-2464-2023 REASON:...Read More

Company: Stryker Corporation Date of Enforcement Report: 08/25/2023 Class II PRODUCT SurgiCount+ Software Application-indicated as an adjunctive technology for augmenting the manual process of counting, displaying and recording the number of RFID-tagged absorbent articles used during surgical procedures Product Code: 0694-002-090. Recall Number: Z-2463-2023 REASON: Potential for current software to miscount when scanning in multiple...Read More