Company: Outset Medical, Inc. Date of Enforcement Report: 4/07/2023 Class II PRODUCT Outset Tablo Model Numbers (REF): PN-0006000 PN-0007001 Tablo is a next generation, self-contained hemodialysis system (Hemodialysis System or System), intended for acute, home and chronic dialysis therapy with or without ultrafiltration, in an acute or chronic care facility. Recall Number: Z-1351-2023 REASON: An...Read More

Company: Shanghai United Imaging Healthcare Co., Ltd Date of Enforcement Report: 4/7/2023 Class II PRODUCT Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography (PET) and Computed Tomography (CT), Model uMI 550 Part Number: 88000657 88000057 Recall Number: Z-1353-2023 REASON: Due to a software issue where the process of patient scanning, the scatter correction may...Read More