Company:  Draeger Medical, Inc. Date of Enforcement Report:  6/27/2018 PRODUCT Apollo Anesthesia Machine; Cat. no. 8605310 Product Usage:  Indicated as a continuous flow anesthesia system. The Apollo may be used for manually assisted or automatic ventilation, delivery of gases and anesthetic vapor, and monitoring of oxygen and CO2 concentration, breathing pressure, respiratory volume, and anesthetic agent concentration and identification....Read More

Company: Cyberonics, Inc. Date of Enforcement Report 6/27/2018 Class II: PRODUCT VNS Therapy Programmer, Model 3000, v1.0 System Recall Number: Z-2255-2018 REASON Certain Model 3000 programming events can result in miscalculation of parameters stored in the Models 103, 104, 105, and 106 generators. During these programming events, the miscalculations can lead to: ” Delivery of...Read More

Company:C.R. Bard, Inc. Date of Enforcement Report 6/27/2018 Class II: PRODUCT CritiCore Automated Urine Output and Temperature Monitor Recall Number: Z-2243-2018 REASON Issues identified with the monitor including urine output measurement errors, temperature measurement errors and undesired alarms.. RECALLING FIRM/MANUFACTURER C.R. Bard, Inc. Covington, GA on 11/10/2017. Voluntary: Firm Initiated recall is ongoing. VOLUME OF...Read More

Company: Datex-Ohmeda, Inc. Date of Enforcement Report 6/27/2018 Class II: PRODUCT CARESCAPE R860 ventilators with software version 10SP05 Product Usage: The CARESCAPE R860 ventilator is designed to provide mechanical ventilation or support to neonatal, pediatric, and adult patients weighing 0.25 kg and above. The CARESCAPE R860 ventilator is a microprocessor based, electronically controlled, pneumatically driven...Read More

Company: Draeger Medical, Inc. Date of Enforcement Report 6/27/2018 Class II: PRODUCT Apollo Anesthesia Machine; Cat. no. 8605310Product Usage:Indicated as a continuous flow anesthesia system. The Apollo may be used for manually assisted or automatic ventilation, delivery of gases and anesthetic vapor, and monitoring of oxygen and CO2 concentration, breathing pressure, respiratory volume, and anesthetic...Read More

Company: Draeger Medical, Inc. Date of Enforcement Report 6/27/2018 Class II: PRODUCT Perseus A500 Anesthesia Machine; Cat. no. MK06000Product VProduct Usage:Intended for use in anesthetizing adults, children, and neonates and can be used for automatic and manual ventilation, pressuresupported spontaneous breathing, and spontaneous breathing. Perseus is equipped with airway monitoring, gas measurement and device monitoring,...Read More

Company: Draeger Medical, Inc. Date of Enforcement Report 6/27/2018 Class II: PRODUCT Fabius GS Tiro Anesthesia Machine; Cat. no. 8606000 Product Usage: Inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O, and AIR supplied by a medical gas pipeline system or by externally mounted gas cylinders....Read More

CompanyDraeger Medical, Inc.Date of Enforcement Report 6/27/2018 Class lI: PRODUCT Perseus A500 Anesthesia Machine; Cat. no. MK06000Product VProduct Usage:Intended for use in anesthetizing adults, children, and neonates and can be used for automatic and manual ventilation, pressuresupported spontaneous breathing, and spontaneous breathing. Perseus is equipped with airway monitoring, gas measurement and device monitoring, Recall Number:...Read More

CompanyDraeger Medical, Inc.Date of Enforcement Report 6/27/2018 Class lI: PRODUCT Fabius GS Tiro Anesthesia Machine; Cat. no. 8606000 Product Usage: Inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O, and AIR supplied by a medical gas pipeline system or by externally mounted gas cylinders. Fabius series...Read More

CompanyDraeger Medical, Inc.Date of Enforcement Report 6/27/2018 Class lI: PRODUCT Fabius GS Premium Anesthesia Machine; Cat. no. 8607000 Product Usage: Inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O, and AIR supplied by a medical gas pipeline system or by externally mounted gas cylinders. Fabius series...Read More

CompanyDraeger Medical, Inc.Date of Enforcement Report 6/27/2018 Class lI: PRODUCT Fabius GS MRI Anesthesia Machine; Cat. no. 8607300 Product Usage: Inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O, and AIR supplied by a medical gas pipeline system or by externally mounted gas cylinders. Fabius series...Read More

Company:Cyberonics, Inc. Date of Enforcement Report 6/27/2018 Class lI: PRODUCT VNS Therapy Programmer, Model 3000, v1.0 System Recall Number: Z-2255-2018 REASON Certain Model 3000 programming events can result in miscalculation of parameters stored in the Models 103, 104, 105, and 106 generators. During these programming events, the miscalculations can lead to: ” Delivery of more...Read More

Company:C.R. Bard, Inc. Date of Enforcement Report 6/27/2018 Class lI: PRODUCT CritiCore Automated Urine Output and Temperature Monitor Recall Number: Z-2243-2018 REASON Issues identified with the monitor including urine output measurement errors, temperature measurement errors and undesired alarms.. RECALLING FIRM/MANUFACTURER C.R. Bard, Inc. Covington, GA on 11/10/2017. Voluntary: Firm Initiated recall is ongoing. VOLUME OF...Read More

Company:Datex-Ohmeda, Inc.Date of Enforcement Report 6/27/2018 Class lI: PRODUCT CARESCAPE R860 ventilators with software version 10SP05 Product Usage: The CARESCAPE R860 ventilator is designed to provide mechanical ventilation or support to neonatal, pediatric, and adult patients weighing 0.25 kg and above. The CARESCAPE R860 ventilator is a microprocessor based, electronically controlled, pneumatically driven ventilator that...Read More

CompanyDraeger Medical, Inc.Date of Enforcement Report 6/27/2018 Class lI: PRODUCT Apollo Anesthesia Machine; Cat. no. 8605310Product Usage:Indicated as a continuous flow anesthesia system. The Apollo may be used for manually assisted or automatic ventilation, delivery of gases and anesthetic vapor, and monitoring of oxygen and CO2 concentration, breathing pressure, respiratory volume, and anesthetic agent concentration...Read More