June 24, 2015
Company: Philips Ultrasound Inc Date of Enforcement Report 6/24/2015 Class lI: PRODUCT Philips Ultrasound, Model Q-Station, with software version 3 or higher, Catalog number: 795088; Part Number: 989605382391 Q-Station is application software intended to manage, view, analyze, and report qualitative and quantitative image data from ultrasound exams. It is designed to host optional advanced analysis...
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Company: Mortara Instrument, Inc Date of Enforcement Report 6/24/2015 Class lI: PRODUCT ELI 380 Electrocardiograph. The ELI 380 is intended to be a high-performance, multichannel resting electrocardiograph. As a resting electrocardiograph, the ELI 380 simultaneously acquires data from each lead. Once the data is acquired, it can be analyzed, reviewed, stored, printed or transmitted. It...
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Company: CareFusion 303, Inc. Date of Enforcement Report 6/24/2015 Class lI: PRODUCT Alaris PC unit model 8015, software version 9.17 Infusion Pump. Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System. The software is embedded in the Alaris PC unit. Recall Number Z-1811-2015 REASON CareFusion...
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Company: Boston Scientific Corporation Date of Enforcement Report 6/24/2015 Class lI: PRODUCT CLEARSIGN II Amplifier for LABSYSTEM PRO EP Recording System, 120 channels, using firmware version 2.08. The channel numbers in the amplifier are as follows: Material number: H30120020210 – 40 Channel CLEARSIGN II Amplifier, catalog number 2002021; Material number: H30120020220 80 Channel CLEARSIGN II...
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