Healthcare International, Inc.

Sigma Spectrum VOLUMETRIC INFUSION PUMP, with or without Master Drug Library, Part Number 35700 -- Common/Classification Name: Infusion Pump --Class 2 medical device -- SIGMA LLC, Medina, NY 14103 -- Shipping box label: Infusion Pump SIGMA Model 35700 (with accessories), SIGMA International, Inc. Medina, NY 14103 ** Serial Number: XXXXXX. To be used in a healthcare facility in an IV pole mounted configuration or carried by the user in an ambulatory manner.

FDA Recall

Terminated ·Sigma International General Medical Apparatus, Llc·Product code FRN·September 15, 2010

Signa Excite 1.5T, Signa HD 1.5T, Signa HDx 1.5T, Signa HDxT 1.5T, Signa HDe, GE DISCOVERY MR450 and the Signa 3.0T MR750 MRI systems when used in conjunction with Confirma's CADstream (These systems contain the PURE software option.) Excite MR system is indicated for use as a diagnostic imaging device to produce images of the internal structures and organs of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body.

FDA Recall

Terminated ·GE Medical Systems, LLC·Product code LNH·October 6, 2009

Spacelabs Healthcare Xhibit Central Station, Model 96102 is used to provide clinicians with central monitoring of patient data for those patients connected to networked Spacelabs Healthcare patient monitors and telemetry transmitters.

FDA Recall

Terminated ·Spacelabs Healthcare Inc·Product code MHX·February 26, 2016

Spacelabs Healthcare elance Vital Signs Monitor, Model 93300, with Option S. It is a patient monitor with arrhythmia detection or alarms.

FDA Recall

Terminated ·Spacelabs Healthcare, Llc·Product code MHX·October 17, 2013

Respironics V60 Ventilator, manufactured by Respironics California Inc. in Carlsbad, CA.

FDA Recall

Terminated ·Respironics California Inc·Product code MNT·July 2, 2010

Cuffable Blood Pressure Cuffs; Manufactured for Vital Signs, Inc., a GE Healthcare Company 20 Campus Road, Totowa, NJ 07512 Made in Mexico. The cuff is used to determine a subject's blood pressure.

FDA Recall

Terminated ·GE Healthcare, LLC·Product code DXQ·April 26, 2011

Spacelabs Healthcare Xhibit Telemetry Receiver (XTR), Model 96280. Xhibit Telemetry Receivers (XTR) must be connected to an Xhibit Central Station for the display of patient vital signs.

FDA Recall

Terminated ·Spacelabs Healthcare Inc·Product code MHX·August 25, 2016

Spacelabs Healthcare Xhibit Central Station, Model 96102, Version 1.1.2. Xhibit Telemetry Receivers (XTR) must be connected to an Xhibit Central Station for the display of patient vital signs.

FDA Recall

Terminated ·Spacelabs Healthcare Inc·Product code MHX·August 25, 2016

MicroScan Synergies Plus Negative Panels, 20 panels per box Medical device designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification to the species level of colonies, grown on solid media, of rapidly growing aerobic and facultative anaerobic gram-negative bacteria. Catalog Nos. B1016-200, B1016-201, B1016-202, B1016-203, B1025-103, B1025-104, B1025-105, B1025-106, B1025-107, B1025-108, B1025-109, B1025-112, and B1027-101

FDA Recall

Terminated ·Siemens Microscan·Product code JWY·July 31, 2008

91496 Ultraview SL Command Module, Options A, B, C, and I. Option A: ECG/Respiration, SpO2, Temperature x2 & adult/neonate NIBP. Option B: ECG/Respiration, Invasive Pressure x2, SpO2, Temperature x2 & adult/neonate NIBP. Option C: ECG/Respiration, Invasive Pressure x4, SpO2, Cardiac Output, Temperature x2 & adult/neonate NIBP. Option I: SpO2, Temperature x2, & adult/neonate NIBP.

FDA Recall

Terminated ·Spacelabs Healthcare Inc·Product code DSI·July 1, 2016

Dura Guard, Dural Repair Patch with Apex Processing. For use as a dura substitute for the closure of dura mater during neurosurgery. Product Code: DG0209SN DG0209SN DG0209SN DG0209SN DG0209SN DG0209SN DG0209SN DG0209SN DG0404SN DG0404SN DG0404SN DG0404SN DG0404SN DG0404SN DG0404SN DG0404SN DG0404SN DG0404SN DG0404SN DG0404SN DG0404SN DG0404SN DG0404SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN

FDA Recall

Terminated ·Synovis Surgical Innovations, Inc.·Product code GXQ·October 28, 2013

Nellcor brand Pulse Oximeter, model N-395, Made in Ireland; Distributed by Tyco Healthcare Group, LP, Nellcor Puritan Bennett, Inc., Pleasanton, CA 94588 U.S.A.

FDA Recall

Terminated ·Nellcor Puritan Bennett·Product code DQA·October 18, 2004

Nellcor brand OxiMax Pulse Oximeter, model number N-595 Made in Ireland; Distributed by Tyco Healthcare Group, LP, Nellcor Puritan Bennett, Inc., Pleasanton, CA 94588 U.S.A.

FDA Recall

Terminated ·Nellcor Puritan Bennett·Product code DQA·October 18, 2004

Mortara Surveyor S12 and Surveyor S19 Patient Monitors. Product Usage: They are indicated for use in adult & pediatric patient populations. They facilitate the monitoring of: Non-invasive blood pressure (NIBP), Impedance respiration, Invasive blood pressure (P1-P4), Temperature, Functional arterial oxygen saturation (SpO2), End-tidal & inspired CO2, ECG monitoring with arrhythmia and ST-segment analysis, 12-Lead resting ECG, Cardiac output (C)). The Mortara Surveyor Patient Monitor is a prescription device intended to be used by healthcare professionals in all areas of a healthcare facility.

FDA Recall

Terminated ·Mortara Instrument, Inc·Product code MHX·October 7, 2014

FlowCOUPLER. An implantable device that is used to detect blood flow in vessels. Used in the end-to-end anastomosis of veins and arteries normally encountered in microsurgical and vascular reconstructive procedures. The FlowCOUPLER System is intended to detect blood flow and confirm vessel patency intra-operatively and post-operatively at the anastomotic site. Baxter Healthcare.

FDA Recall

Terminated ·Baxter Healthcare Corporation·Product code DPW·July 11, 2014

CADD-MS 3 Ambulatory Infusion Pump, Model 7400 Smiths Medical MD, Inc., St. Paul, MN 55112 USA. Electromechanical pumps used for general drug delivery infusion therapies. Used mainly by home care patients but can also used in health care facilities.

FDA Recall

Terminated ·Smiths Medical MD, Inc.·Product code FRN·March 7, 2008

Disposable Temperature Probes, (sterile), Sensor diameter: 3mm/0.12 in; 25 units per box. Vital Signs Inc. a GE Healthcare Company, 20 Campus Road, Totowa, NJ 07512 USA, www.gehealthcare.com/vitalsigns. Continuous temperature monitoring.

FDA Recall

Terminated ·Vital Signs Devices, a GE Healthcare Company·Product code FLL·July 18, 2013

Medtronic Soletra 7426, Quadripolar Multi-Programmable Neurostimulator for Deep Brain Stimulation, Rx only, Medtronic, Inc., Minneapolis, MN 55432-5604 USA (The Medtronic Activa System in an implantable, multiprogrammable quadripolar system that delivers electrical stimulation to selected areas of the brain)

FDA Recall

Terminated ·Medtronic Neuromodulation·Product code MHY·October 1, 2007

Medtronic Kinetra 7428, Dual Program Neurostimulator for Deep Brain Stimulation, Rx only, Medtronic, Inc., Minneapolis, MN 55432-5604 USA. (The Medtronic Kinetra Model 7428 Neurostimulator is a multiprogrammable device and a component of the Kinetra Neurostimulator System for deep brain stimulation.)

FDA Recall

Terminated ·Medtronic Neuromodulation·Product code MHY·October 1, 2007

Spacelabs Pediatric Flow Sensor Kit, PN: 376-0561-00. This kit is for Spacelabs Healthcare Blease 700/900 Series Ventilators. Designed specifically for the mechanical ventilation of adult and pediatric patients under general anesthesia.

FDA Recall

Terminated ·Del Mar Reynolds Medical, Ltd.·Product code CBK·March 5, 2015