Company: Siemens Healthcare Diagnostics, Inc. Date of Enforcement Report 9/21/2016 Class lI: PRODUCT Siemens RAPIDPoint 500 Blood Gas Analyzer Siemens Material Number (SMN): 10492730, 10696855, 10696857, 10697306 Recall Number Z-2799-2016 REASON There is a potential for the first and/or last name of one patient to be printed with Patient ID and result data from a...Read More

Company: Siemens Healthcare Diagnostics, Inc. Date of Enforcement Report 9/21/2016 Class lI: PRODUCT Siemens RAPIDPoint 405 Blood Gas Analyzer nBili Siemens Material Number (SMN): 10282093, 10310464, 10314817, 1031 7193, 10318999, 10320055, 10321238, 10322347, 10328278, 10328302, 10336784 Recall Number Z-2798-2016 REASON There is a potential for the first and/or last name of one patient to be...Read More

Company: Siemens Healthcare Diagnostics, Inc. Date of Enforcement Report 9/21/2016 Class lI: PRODUCT RAPIDLab 1265 Blood Gas Analyzer Siemens Material Number (SMN): 10321852, 10470366, 10491395 Recall Number Z-2803-2016 REASON There is a potential for the first and/or last name of one patient to be printed with Patient ID and result data from a different patient,...Read More

Company: Siemens Healthcare Diagnostics, Inc. Date of Enforcement Report 9/21/2016 Class lI: PRODUCT RAPIDLab 1260 Blood Gas Analyzer Siemens Material Number (SMN): 10321846, 10491394 Recall Number Z-2802-2016 REASON There is a potential for the first and/or last name of one patient to be printed with Patient ID and result data from a different patient, even...Read More

Company: Siemens Healthcare Diagnostics, Inc. Date of Enforcement Report 9/21/2016 Class lI: PRODUCT RAPIDLab 1245 Blood Gas Analyzer Siemens Material Number (SMN): 10321844, 10337179, 10491393 Recall Number Z-2801-2016 REASON There is a potential for the first and/or last name of one patient to be printed with Patient ID and result data from a different patient,...Read More

Company: Siemens Healthcare Diagnostics, Inc. Date of Enforcement Report 9/21/2016 Class lI: PRODUCT Siemens RAPIDLab 1240 Blood Gas Analyzer Siemens Material Number (SMN): 10321840, 10491392 Recall Number Z-2800-2016 REASON There is a potential for the first and/or last name of one patient to be printed with Patient ID and result data from a different patient,...Read More

Company: Hospira Inc. Date of Enforcement Report 9/21/2016 Class lI: PRODUCT Hospira MedNet Medication Management Suite software, version 6.1, List Numbers 16037-64-02 and 16037-64-03, in combination with the SapphirePlus 13.1x infusion pump Hospira MedNet Medication Management Suite is intended to facilitate networked communication between compatible computer systems and Hospital infusion pumps.. Recall Number Z-2790-2016 REASON...Read More

Company: Thermo Finnigan LLC. Date of Enforcement Report 9/21/2016 Class lI: PRODUCT Endura MR Mass Spectrometer u using software versions Endura MD Software 1.0 and 1.0 SP1. In vitro diagnostic medical device used to identify and quantify inorganic and organic compounds in the human body. Chemistry: In vitro diagnostic medical device used to identify and...Read More