PRODUCT Magnetom 42 SP Magnetic Resonance Imaging System with Software Version Number 2A2.7B. Computer aided medical device generates magnetic field resulting in a digital image of the body: a) Magnetom 42 SP Magnetic Resonance Imaging Systems, Model No. 89 69 131 (SP-A); b) Magnetom 42 SP Magnetic Resonance Imaging Systems, Model No. 87-29-485 (SP). Recall...Read More

2/24/00 Class II PRODUCT Aeroset Assay Disks, V3.0 Conventional Units, used as a software diskette to upgrade the Aeroset System, which is a clinical chemistry analyzer, used for in-vitro diagnostic tests. Recall #Z-488-0. REASON The disks are improperly duplicated and contain software that will install System International (SI) units, rather than conventional units as labeled....Read More

All Architect I System Processing Modules with Software Versions1.0 and 1.01. Recall #Z-910-9. REASON The device may report incorrect results for diluted samples; and/or when used with the Laboratory Information System or Host Information Systems, the system may incorrectly associate test results with patient ID or incorrectly associate control results with patient records. CODE List...Read More