Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 5/4/2016 Class lI: PRODUCT SOMATOM Force, Computed Tomography x-ray system intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission. Recall Number Z-1558-2016 REASON The Neonate Head protocol with the pediatric kernel Hp38 could result in artefacts and possibly lead to...Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 5/4/2016 Class lI: PRODUCT ACUSON X700 Ultrasound System with software version 1.0.04. Model numbers: 10658844 ACUSON X700 Ultrasound System 10658846 – ACUSON X700 Ultrasound System (Russia) 10658845 – ACUSON X700 Ultrasound System (Korea) Radiology: The Siemens ACUSON X700 ultrasound imaging system is intended for the following...Read More

Company: Roche Molecular SystemsDate of Enforcement Report 5/4/2016 Class lI: PRODUCT Hand-Held Scanner USB IT3800 For sample identification and tracking when used with various systems. Recall Number Z-1578-2016 REASON The hand-held barcode scanner model IT3800 used with the COBAS AmpliPrep instrument mis-identified a sample barcode ID. RECALLING FIRM/MANUFACTURER Roche Molecular Systems, Branchburg, NJ on 3/3/2016....Read More

Company: Philips Visicu Date of Enforcement Report 5/4/2016 Class lI: PRODUCT IeCareCoordinator allows the customer to schedule patient tasks (i.e., take weight measurement, take blood pressure). For medical use by professional medical staff. Recall Number Z-1557-2016 REASON The adherence check generates a software error. Two issues occur as a result of the software error: 1)...Read More

Company: Philips and Neusoft Medical Systems Co., Ltd. Date of Enforcement Report 5/4/2016 Class lI: PRODUCT NeuViz 16 Multi-Slice CT Scanner System PN: 989605858501 a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array with multi-slice capability up to 16 slices simultaneously. Recall Number Z-1573-2016 REASON The following issues...Read More

Company: Mindray DS USA, Inc. dba Mindray North America Date of Enforcement Report 5/4/2016 Class lI: PRODUCT Panorama Patient Monitoring Network Mindray DS USA The Panorama Patient Monitoring can view recal time, store, print, graph and trend patient clinical and demographic data. The Panoram Patient Monitoring Network can sent independent alarm limits for data send...Read More

Company: Intuitive Surgical, Inc. Date of Enforcement Report 5/4/2016 Class lI: PRODUCT EndoWrist Stapler 45 and Stapler 30 instruments used on the da Vinci Xi systems (IS4000) with p5 software. General Surgery: The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive...Read More

Company: Horiba Instruments Inc Date of Enforcement Report 5/4/2016 Class lI: PRODUCT Pentra C400 (version 1.1.2 or lower) The ABX PENTRA 400 and 400C are discrete photometric bench top chemistry analyzers for clinical use. The device is intended to duplicate manual analytical procedures by performing various steps such as pipetting, mixing, heating and measuring color...Read More