Smiths Medical ASD Inc. - BCI Advisor Vital Signs Monitor, Model 9200 - Class 2 Recall
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 ...
Source: Medical Device Recalls - July 7, 2018 Category: Medical Devices Source Type: alerts
Shimadzu Medical Systems - Sonialvision Safire II, Model : DAR8000f - Class 2 Recall
Sonialvision Safire II, Model #: DAR-8000f Product Usage: This angiographic x-ray system device intended to be used for the radiography in the hospital with X-ray devices. This device is operated and used by the physicians and X-ray technologist. The object of this device is total patient population. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 15, 2018 Category: Medical Devices Source Type: alerts
Baxter Healthcare Corporation - Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6 and Version 8) - Class 2 Recall
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), infusion pump, 35700BAX2 Product Usage: The Baxter SIGMA Spectrum Infusion Pump with Master Drug Library is intended to be used for the controlled administration of fluids. These fluids may include pharmaceutical drugs, blood, blood products and mixture of required patient therapy. The intended routes of administration consist of the following clinically accepted routes: intravenous, arterial, subcutaneous, intrathecal, epidural or irrigation of fluid space. Spectrum Infusion Pump is intended to be used in conjunction with legally marketed intraveno...
Source: Medical Device Recalls - June 8, 2018 Category: Medical Devices Source Type: alerts
Baxter Healthcare Corporation - Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6 and Version 8) - Class 2 Recall
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), infusion pump, 35700BAX and 35700ABB Product Usage: The Baxter SIGMA Spectrum Infusion Pump with Master Drug Library is intended to be used for the controlled administration of fluids. These fluids may include pharmaceutical drugs, blood, blood products and mixture of required patient therapy. The intended routes of administration consist of the following clinically accepted routes: intravenous, arterial, subcutaneous, intrathecal, epidural or irrigation of fluid space. Spectrum Infusion Pump is intended to be used in conjunction with legally market...
Source: Medical Device Recalls - June 8, 2018 Category: Medical Devices Source Type: alerts
Draeger Medical Systems, Inc. - Draeger Jaundice Meter JM103 - Class 1 Recall
Draeger Jaundice Meter JM-103 The device is intended for use in hospitals, clinics or doctor s offices under a physician s supervision / direction to assist clinicians in monitoring of newborn infants. The device is not intended as a standalone for diagnosis of hyperbilirubinemia. It is to be used in conjunction with other clinical signs and laboratory measurements. The Jaundice Meter is not intended for home use. The Jaundice Meter may only be used at the sternum measurement site for Physician s office applications (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 7, 2018 Category: Medical Devices Source Type: alerts
