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    enGen Laboratory Automation Systems (enGen) with TCAutomation -- For in vitro quantitative measurement of a variety of analytes of clinical interest; for pre-analytical and post-analytical sample and data management. --- Background: The enGen Lab Automation System is a modification to VITROS Analyzers that includes the addition of an automated track sub-system (TCAutomation) for pre-analytical and post-analytical sample and data management. In addition to an Automated Track Sub-system, the enGen System includes one or more VITROS Chemistry, Immunodiagnostic and/or Integrated Systems (clinical analyzers) as well as a Data Management Subsystem (Middleware), and a Software Configuration (gsb) File. The enGen System is typically interfaced with a Laboratory Information System (LIS) via connectivity facilitated at the Data Management Subsystem level. The Bypass Module is an analyzer specific module that interfaces clinical analyzers to the enGen System and allows for aspirating patient samples directly from the clinical analyzers. A sample tube carrier sensor in the Bypass Module is used to detect sample tube carriers as they leave the metering location of the Bypass. If a tube carrier is not detected within a defined period of time (6.4 seconds) the next sample to be metered may not advance for processing.

    FDA Enforcement
    Class II ·Terminated·Ortho-Clinical Diagnostics·June 18, 2014

    CARTO 3 V1.05(FG-5400-00). The CARTO 3 V1.05 System is intended for catheter-based atrial and ventricular mapping. The mapping system allows real-time display of cardiac maps in a number of different formats. Maps may be displayed as cardiac electrical activation maps, cardiac electrical propagation maps, cardiac electrical potential maps, impedance maps and cardiac chamber geometry maps. The acquired patient signals, including body surface ECG and intracardiac electrograms may also be displayed in real time on the System's display screen. The CARTO 3 V1.05 System is also intended to support EP procedures, maintaining CARTO¿ XP System capabilities, in the presence of a high metallic environment and provide a data communication channel to the Stereotaxis Niobe Catheter Guidance System as well as in a regular EP lab. The CARTO 3 V1.05 System includes the CartoMerge capability to import, register and merge CT or MRI structural images with CARTO Maps physiological information and real time catheter navigation, the Fast Anatomical Mapping (FAM) functionality, enabling creation of cardiac maps using'catheters with magnetic proximal and distal location sensors and the CartoSound image integration functionality, that enables integration of intracardiac echo (ICE) visualization to provide 3D combined maps. In addition to the use of specialized navigation catheters, the system is also intended for use with non-navigational electrophysiology catheters.

    FDA Enforcement
    Class II ·Terminated·Biosense Webster, Inc.·September 19, 2012

    BCI Advisor Vital Signs Monitor, Model 9200, Reorder numbers 920654235, 920654235, 920654335A, and 920674235A. (The differences in the reorder numbers have to do with certain functions being installed or not installed.) Product Usage: The 9200 vital signs monitor is intended to be used in the ICU, CCU, OR, ER, RR, Labor and Delivery rooms, special procedure labs and other areas of the hospital or clinic where low end monitoring systems are needed. The basic monitor package includes ECG (3 lead/5 lead), impedance respiration (RSP), non-invasive blood pressure (NIBP), pulse oximetry (SpO2), two invasive blood pressures (P1 and P2), and two temperature channels (T1 and T2). Capnography (ETCO2, inCO2, RR), a two-inch internal, graphical/alphanumeric printer and a battery are provided as options. The device permits patient monitoring with adjustable alarm limits as well as visible and audible alarm signals. The device will provide fast, reliable measurements on patients ranging from neonate to adults when using the appropriate BCI accessories. The impedance respiration and capnography parameters are available in adult and pediatric mode only and are not intended for neonatal monitoring. The monitor may be connected to the Life Sensing Instrument Company, Inc. HTS 820 Central Station for remote monitoring of patient status. The monitor is not intended for home use. The monitor is not intended to be an apnea monitor. It was not designed or validated for use as an apnea monitor.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD Inc.·July 18, 2018

    enGen (TM) Laboratory Automation System configured with Thermo Scientific Recapper Module (230V or 110V -- COMMON/USUAL NAME: enGen (TM) Track System -- NOTE: Outside the US the system is also known as VITROS Automation Solution (VAS) TC Automation System (configured with Thermo Scientific Recapper Module from VITROS Automation Solutions), Product Code 6844300 --- The enGen (TM) Lab Automation System is a modification to VITROS Analyzers that includes the addition of an automated track sub-system (TC Automation) for pre-analytical and post-analytical sample and data management. In addition to an Automated Track Sub-system, the enGen (TM) System includes one or more VITROS Chemistry, Immunodiagnostic and/or Integrated Systems (clinical analyzers) as well as a Data Management Subsystem (Middleware), and a Software Configuration (gsb) File. The enGen System is typically interfaced with a Laboratory Information System (LIS) via connectivity facilitated at the Data Management Subsystem level. The enGen (TM) Laboratory Automation System contains a module (i.e. enGen (TM)Laboratory Automation Recapper Module) that applies caps to the sample collection container after the sample has been aspirated. In this module, an electrical cable supplies power to the cap vibratory feeder and is supposed to be located above the vibratory feeder support plate. The cap vibratory feeder sits upon a feeder support plate. Un-capped sample containers pass underneath this support plate prior to being re-capped for storage. The Recapper Module is supplied by Thermo Fisher Scientific.

    FDA Enforcement
    Class II ·Terminated·Ortho-Clinical Diagnostics·May 4, 2016

    Centurion-Surgical Tray MNS10255 DELIVERY TRAY MNS10255 DELIVERY TRAY MNS10310 MEATOTOMY TRAY MNS10310 MEATOTOMY TRAY MNS10525 DELIVERY INSTRUMENT TRAY MNS10620 PACEMAKER TRAY MNS10820 ENT/EPISTAXIS KIT MNS10920 PODIATRY NAIL PACK MNS10985 CERCLAGE REMOVAL KIT MNS11020 VAGINAL DELIVERY TRAY MNS11040 OB DELIVERY PROCEDURE PACK MNS11040 OB DELIVERY PROCEDURE PACK MNS11180 CUTDOWN TRAY MNS11380 CYSTO PROCEDURE KIT MNS11415 BIRTHING SET MNS11430 MYELOGRAM TRAY MNS11485 DERM ROOM TRAY MNS11490 VASECTOMY TRAY MNS11490 VASECTOMY TRAY MNS11605 STERILE FLUORO SSP TRAY MNS11720 OCULOPLASTICS INSTRUMENT SET MNS11780 MOHS INSTRUMENT PACK MNS11885 OB BASIC DELIVERY INSTRUMENT TRAY MNS11980 DERMATOLOGY TRAY MNS12045 LINE REPAIR KIT MNS12090 TOENAIL REMOVAL PACK MNS12140 HAND TRAY MNS12175 PACEMAKER TRAY MNS1320 E.N.T. TRAY MNS1445 VASECTOMY MNS1485 NOSEBLEED TRAY MNS1500 JOINT ASPIRATION KIT MNS1500 JOINT ASPIRATION KIT MNS1545 LATEX FREE NASAL HEMORRHAGE SET MNS1555 EPISTAXIS TRAY MNS1900 NOSEBLEED TRAY MNS1990 NASAL KIT MNS2105 EPISTAXIS TRAY MNS2170 NASAL PACKING TRAY MNS2225B MYELOGRAM TRAY MNS2225B MYELOGRAM TRAY MNS2845 U/S, BASIC BIOPSY TRAY MNS2975 ENT EPISTAXIS TRAY MNS3345A PEDIATRIC CUTDOWN TRAY MNS3450 IUD TRAY MNS3490 CHEMO KIT MNS3925 OB INSTRUMENT TRAY MNS4090A MINOR CUTDOWN TRAY MNS4110 THORACOTOMY TRAY MNS4120 NOSEBLEED TRAY MNS4215 OR VAGINAL DELIVERY TRAY MNS4360 BREAST BIOPSY KIT MNS4405 BIOPSY DERMATOLOGY KIT MNS4545 NASAL TRAY MNS4855 WOUND EXPLORATION/DPL TRAY MNS5170 NEONATAL PROCEDURE TRAY MNS5225 RENAL BIOPSY TRAY MNS5272 OB DELIVERY INSTRUMENT TRAY MNS5410 VAG DELIVERY INSTRUMENTS MNS5410 VAG DELIVERY INSTRUMENTS MNS5425 VAGINAL DELIVERY TRAY MNS5511 ARTHROGRAM TRAY MNS5575 OB DELIVERY TRAY MNS5750A VAGINAL DELIVERY SET MNS6025 GU MEATOTOMY MNS6025 GU MEATOTOMY MNS6260 BIOPSY TRAY MNS6285 MINOR PLASTIC SET MNS6395 VAGINAL DELIVERY KIT MNS6405 MULTI-PURPOSE RADIOLOGY TRAY MNS6820 RADIOLOGIST SPINAL TRAY MNS6880 BIOPSY TRAY MNS6985 PERCUTANEOUS CATHETER PLACEMENT TRAY MNS7155 TONGUE TIE KIT MNS7285 BIOPSY KIT- SHAVE MNS7285 BIOPSY KIT- SHAVE MNS7285 BIOPSY KIT- SHAVE MNS7295 BIOPSY KIT - SHAVE/PUNCH COMBO MNS7325 CATHETER REMOVAL TRAY MNS7415 NASAL HEMORRHAGE TRAY MNS7415 NASAL HEMORRHAGE TRAY MNS7575 MINOR TISSUE TRAY MNS7605 BREAST BIOPSY KIT MNS7815 DERMAL PACK MNS7900 C.T. BIOPSY TRAY MNS8010 EPISTAXIS TRAY MNS8445 SPINAL TRAY MNS8445 SPINAL TRAY MNS8475 ED TRACHEOTOMY TRAY MNS8645 BIOPSY KIT MNS8645 BIOPSY KIT MNS8915 BLOOD CULTURE COLLECTION KIT ; CVAD MNS9005 CENTRAL LINE REMOVAL TRAY MNS9106 ULTRASOUND BIOPSY TRAY MNS9106 ULTRASOUND BIOPSY TRAY MNS9170 CUTDOWN TRAY MNS9245 PACEMAKER TRAY MNS9335 IUD TRAY MNS9455 VAGINAL DELIVERY TRAY W/INSTRUMENTS MNS9480 VAGINAL DELIVERY TRAY MNS9480 VAGINAL DELIVERY TRAY MNS9625 TRACHEOSTOMY KIT MNS965 AMNIOCENTESIS TRAY MNS9710 IUD TRAY MNS9765 PORT INSERTION TRAY MNS9780 ARTHROGRAM TRAY MNS9820 OB PACK MNS9835 VAG DELIVERY TRAY MNS9835 VAG DELIVERY TRAY MNS9855 PACEMAKER INSTRUMENT TRAY MNS9870 DR. NELSON MOHS PACK MNS9870 DR. NELSON MOHS PACK MNS9935 CATH LAB INSTRUMENT KIT

    FDA Enforcement
    Class II ·Terminated·Centurion Medical Products Corporation·February 12, 2020

    enGen (TM) Laboratory Automation System Configured with TCAutomation" Software v3.5 -- For in vitro quantitative measurement of a variety of analytes of clinical interest --- The VITROS 5,1 FS Chemistry System with enGenTM Laboratory Automation System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods.). ---The enGen (TM) Lab Automation System is a modification to VITROS Analyzers that includes the addition of an automated track sub-system (TCAutomation) for pre-analytical and post-analytical sample and data management. In addition to an Automated Track Sub-system, the enGen (TM) System includes one or more VITROS Chemistry, Immunodiagnostic and/or Integrated Systems (clinical analyzers) as well as a Data Management Subsystem (Middleware), and a Software Configuration (gsb) File. The enGen System is typically interfaced with a Laboratory Information System (LIS) via connectivity facilitated at the Data Management Subsystem level. By using the enGen (TM) Laboratory Automation System as a communication interface between the LIS and the clinical analyzers in the laboratory, the user can manage the workflow to the analyzers and other devices as an integrated system. This eliminates the need for the user to program tests for each sample uniquely on each analyzer. Within the enGen (TM) Laboratory Automation System, the physical routing of samples to the correct location is also automatic. The Buffer Module functions either as a location for samples waiting for results or as a storage area for empty sample tube carriers. When a sample is presented to a clinical analyzer via the Bypass module and is metered for testing, the sample remains on the track system in the Buffer module while waiting for the test results to be generated. If all test results are generated as expected and no additional actions are required, the sample is routed to a designated Exit module where it can be removed from the track system by the user. However, there are certain situations in which a follow-up action (retest of the sample) may be necessary. In these situations, the sample is routed back to a clinical analyzer via the Bypass module to complete the follow-up action. Examples of situations requiring a retest include, but are not limited to: repeat testing when a "No Result"is generated during the initial test event, sample dilution when an out of range result is obtained during the initial test event, and routing to an alternate analyzer when the first analyzer the sample is sent to is unavailable for testing. Once the follow-up sample metering actions are complete, the sample is routed to Buffer module where it remains until testing is complete. Once all test results are obtained the sample is routed to the designated Exit module.

    FDA Enforcement
    Class II ·Terminated·Ortho-Clinical Diagnostics·June 18, 2014

    Custom Surgical Kits containing Medtronic Covidien Devon(TM) Light Gloves: ANGIO TRAY, REF 50-12127; NEURO SPINE TRAY, LAP CHOLE TRACECART(R), REF 53-1931; MINOR PROCEDURE TRACECART (R), REF 53-1932; MAJOR PROCEDURE TRACECART (R), 53-1933; Cover Light Handle Flexible, REF 5-3479-1; LAPAROSCOPY TRAY, REF 89-3605; KNEE/ARTHROSCOPY TRAY, REF 89-3606; SHOULDER/ARTHROSCOPY TRAY, REF 89-3607; LOWER EXTREMITY TRAY, REF 89-3609; BASIC TRAY, REF 89-3610; HAND TRAY, REF 89-3611; NEURO SPINE TRAY, REF 89-3808; NEURO CRANIOTOMY TRAY, REF 89-3809; BASIC SET UP TRAY, REF 89-4137; BASIC PACK, REF 89-4798; SJCHS EXTREMITY TRAY, REF 89-4832; TOTAL KNEE TRAY PGYBK, REF 89-4902; ORTHO SPINE TRAY, REF 89-4935; MAJOR EXTREMITY PACK, REF 89-5057; STANDARD LAP CHOLE PACK, REF 89-5059; UROLOGY CYSTO PACK, REF 89-5246; LAPAROSCOPIC CHOLE PACK, REF 89-5259; FACELIFT & EYELID PACK, REF 89-5609; FACELIFT PACK, REF 89-5611; LAPAROSCOPY PACK, REF 89-5978; HYSTEREOSCOPY TRAY, REF 89-5979; CABG PACK PGYBK A & B, REF 89-5985; OPHTHALMOLOGY PACK PGYBK, REF 89-6263; VASCULAR DRAPE PACK, REF 89-6264; HEART PACK PGYBK, REF 89-6341; SHOULDER PACK, REF 89-6354; MINOR CUSTOM PACK, REF 89-6374; CATARACT PACK PGYBK, REF 89-6377; SURGI-START KIT, REF 89-6378; PACEMAKER PACK, REF 89-6396; GENERAL LAPAROSCOPIC PACK, REF 89-6409; OPEN HEART PROCEDURE PACK TOTAL, REF 89-6508; TOTAL HIP PACK A&B, REF 89-6798; KNEE PACK A&B, REF 89-6799; MAIN OH SUPPLY A&B PACK, REF 89-6855; CRANIOTOMY PACK, REF 89-7017; PACEMAKER PACK, REF 89-7018; GYN MINOR PACK, REF 89-7020; ENT MAJOR PACK, REF 89-7022; GENERAL MAJOR PACK, REF 89-7025; GENERAL MINOR PACK, REF 89-7026; PV PACK, REF 89-7028; GENERAL LAPAROSCOPY PACK, REF 89-7031; CRANIOTOMY PACK, REF 89-7058; LAPAROSCOPY PACK-LF, REF 89-7061; HEAD & NECK PACK, REF 89-7062; VAGINAL HYSTERECTOMY PACK-LF, REF 89-7067; C-SECTION PACK-LF, REF 89-7068; GYN LAPAROSCOPY PACK, REF 89-7075; OPEN HEART PACK, REF 89-7076; C-SECTION PACK, REF 89-7105; TOTAL KNEE PACK, REF 89-7114; ARTHROSCOPY ALL PACK, REF 89-7115; GENERIC ORTHO PACK, REF 89-7116; MINOR EENT PACK, REF 89-7118; COMPANION PACK, REF 89-7189; ENDO VASCULAR PACK, REF 89-7191; OPEN HEART BASIC PACK, REF 89-7281; CUSTOM ER HAND PACK, REF 89-7301; C-SECTION PACK, REF 89-7343; MINOR PACK-LF, REF 89-7390; EXTREMITY PACK, REF 89-7391; ANGIOGRAPHY PACK, REF 89-7398; ANGIOGRAPHY DRAPE PACK PEDI, REF 89-7401; C-SECTION PACK, REF 89-7550; LAMINECTOMY PACK, REF 89-7602; LAPAROSCOPY GEN/UROLOGY PACK, REF 89-7620; LAP CHOLE / APPY TRAY, REF 89-7736; BREAST/TUMMY PACK, REF 89-7737; BASIC PACK, REF 89-7918; LAP CHOLE PACK, REF 89-7924; ROBOTIC SUPPLY URO PACK, REF 89-7990; ROBOTIC SUPPLY GYN PACK, REF 89-7991; SET UP PACK, REF 89-8004; TRAUMA PACK, REF 89-8010; PACEMAKER PACK, REF 89-8191; E HAND PACK, REF 89-8198; NEUROSURGERY PACK, REF 89-8249; SURGERY PACK, REF 89-8261; EYE PACK, REF 89-8273; KNEE PACK, REF 89-8308; SHOULDER PACK, REF 89-8309; HAND PACK, REF 89-8310; PERI/GYN PACK, REF 89-8311; NEURO PACK, REF 89-8372; PODIATRY PACK, REF 89-8379; C-SECTION PACK, REF 89-8394; GENERAL SURGERY PACK, REF 89-8407; GENERAL MALE PACK, REF 89-8409; HAND PACK, REF 89-8416; TOTAL HIP PACK PGYBK, REF 89-8444; TOTAL KNEE PACK PGYBK, REF 89-8445; SURGICAL PODIATRY PACK, REF 89-8464; CATH LAB PACEMAKER PACK, REF 89-8465; BREAST PACK, REF 89-8489; HEAD/NECK PACK, REF 89-8499; EXTREMITY PACK, REF 89-8505; KNEE ARTHROSCOPY PACK, REF 89-8547; SHOULDER ARTHROSCOPY PACK, REF 89-8548; UROLOGY PACK, REF 89-8549; ENT PACK, REF 89-8550; LAMINECTOMY PACK, REF 89-8568; ANT CERV FUSION PACK, REF 89-8652; ENDO BROW FACELIFT PACK, REF 89-8660; PODIATRY PACK, REF 89-8664; GENERAL SURGERY PACK REF 89-8666; Basic Set Up Pack, REF 89-8673; C-SECTION TRAY PGYBK, REF 94-0245; UNIVERSAL BREAST TRAY, REF 94-0266; DR. HAND TRAY, REF 94-0277; FEM-POP TRAY, REF 94-0280 Usage: general surgical

    FDA Enforcement
    Class II ·Terminated·DeRoyal Industries Inc·July 1, 2015