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September 11, 2019
Company: CareFusion 303, Inc. Date of Enforcement Report: 9/11/2019 Class II PRODUCT Alaris EtCO2, Model 8300, UDI: 10885403830013, CareFusion for models 11634567 and 8300ADXeN933 Recall Number: Z-2443-2019 REASON Calibration; it has been determined that the capnographs may have been calibrated during manufacturing using a lower than specified concentration of CO2 RECALLING FIRM/MANUFACTURER CareFusion 303, Inc....
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Company: SonarMed Inc Date of Enforcement Report: 9/11/2019 Class II PRODUCT SonarMed AirWave Monitor, Model Number M0001 Recall Number: Z-2450-2019 REASON Potential for the presence of two error codes which would make the monitor inoperable. RECALLING FIRM/MANUFACTURER SonarMed Inc. on 4/17/2017. Voluntary:  Firm Initiated recall is ongoing. VOLUME OF PRODUCT IN COMMERCE 16 units DISTRIBUTION...
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Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report: 9/11/2019 Class II PRODUCT syngo.CT software version VA48A_SP5.5 in the following SOMATOM computed tomography models: SOMATOM Definition Edge-Model #10590000; SOMATOM Definition AS Model #8098027; SOMATOM Definition Flash Model #10430603 Recall Number: Z-2440-2019 REASON SOMATOM Definition Edge, SOMATOM Definition AS, SOMATOM Definition Flash with software syngo.CT...
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Company: Becton Dickinson & Co. Date of Enforcement Report: 9/11/2019 Class II PRODUCT BD Kiestra InoqulA Software Version 20.3.IVD automated specimen processing Catalog Number: 447202 Recall Number: Z-2438-2019 Recall Number: Z-2439-2019 REASON An anomaly is present in InoqulA / InoqulA+ software version 20.3, has the potential to cause a mismatch between a specimen and plate....
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