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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 10 of 13 Results
510(K) Number: K071073
 
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CARESCAPE PDM-Masimo SpO2. Physiological data monitor. 2 07/23/2021 GE Healthcare, LLC
CARESCAPE Patient Data Module (PDM) used with the following monitors: CARESCAPE B450/B650/B850, SOLA... 2 06/24/2020 GE Healthcare, LLC
Solar 8000i Patient Monitoring System is used to monitor physiologic parameter data on adult, pedia... 2 11/29/2018 GE Healthcare, LLC
CARESCAPE Patient Data Module (PDM) v2.6 software used with CARESCAPE Monitors B850, B650, and B450 ... 2 12/06/2017 GE Medical Systems Information Technologies, Inc.
GE Healthcare Carescape Patient Data Module 2 10/09/2014 GE Healthcare, LLC
GE Healthcare Solar 8000M and Solar 8000i Patient Monitor software version 5.4, 5.5, or 5.6 with the... 2 03/06/2014 GE Healthcare, LLC
CSI, Diamondback 360 Coronary Orbital Atherectomy System, Part Number 70058-02, Model Number DBEC-12... 3 02/26/2014 Cardiovascular Systems, Inc.
SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthcare CARESCAPE Patient D... 2 01/22/2014 GE Healthcare, LLC
GE Healthcare Carescape Patient Data Module The Patient Data Module (PDM) is intended to provide... 2 01/14/2014 GE Healthcare, LLC
SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthcare CARESCAPE Patient D... 2 01/09/2014 GE Healthcare, LLC
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