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Showing 8261–8280 of 8389 results

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Pacific Medical Group Inc.: Pacific Medical GE Corometrics Nautilus Toco Transducer w...

Fetal transducers distributed in advance of receiving 510(k) and international clearances.

FDASep 19, 2019AL, AK, AZ +42 more• Pacific Medical Group Inc.

Pacific Medical Group Inc.: Pacific Medical Philips M1355A Toco Transducer with belt ...

Fetal transducers distributed in advance of receiving 510(k) and international clearances.

FDASep 19, 2019AL, AK, AZ +42 more• Pacific Medical Group Inc.

Axis-Shield Diagnostics, Ltd. 17 Luna Place Dundee United Kingdom: Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGEN...

There is a potential performance issue as detected by an under-recovery of sample results during routine testing.

FDASep 16, 2019Nationwide• Axis-Shield Diagnostics, Ltd. 17 Luna Place Dundee United Kingdom

Unknown Manufacturer: Medicrea Pass LP Trocar K-wire 01.6mm x 500mm-Nitinol Pr...

Conical Cannulated Screws may not accept 1.6mm K-Wire, it cannot enter the minimum tolerance axis threaded

FDASep 16, 2019Nationwide

Icecure Medical Ltd 7, Ha-Eshel Caesarea Israel: IceCure Cryoablation System ProSense -Intended for cryoge...

Updated User Manual DSR3200000 Rev. E to include the safety guidelines in case of any mechanical damage (e.g. bent cryoprobe)

FDASep 16, 2019Nationwide• Icecure Medical Ltd 7, Ha-Eshel Caesarea Israel

Abbott Gmbh & Co. KG Max-Planck-Ring 2 65205 Wiesbaden Germany: Alinity ci Level Sensor, Bulk Solution

Potential reliability issue with the Alinity ci series Level Sensor, Bulk Solution. The development of environmental stress on the bulk solution level sensor can cause cracks.

FDASep 16, 2019Nationwide• Abbott Gmbh & Co. KG Max-Planck-Ring 2 65205 Wiesbaden Germany

Unknown Manufacturer: Medicrea Pass LP Blunt K-wire 01.6mm x 500mm-Nitinol Pro...

Conical Cannulated Screws may not accept 1.6mm K-Wire, it cannot enter the minimum tolerance axis threaded

FDASep 16, 2019Nationwide

Abbott Gmbh & Co. KG Max-Planck-Ring 2 65205 Wiesbaden Germany: Accessory kit, Alinity i containing Alinity ci Level Sens...

Potential reliability issue with the Alinity ci series Level Sensor, Bulk Solution. The development of environmental stress on the bulk solution level sensor can cause cracks.

FDASep 16, 2019Nationwide• Abbott Gmbh & Co. KG Max-Planck-Ring 2 65205 Wiesbaden Germany

Abbott Gmbh & Co. KG Max-Planck-Ring 2 65205 Wiesbaden Germany: Accessory kit, Alinity c containing Alinity ci Level Sens...

Potential reliability issue with the Alinity ci series Level Sensor, Bulk Solution. The development of environmental stress on the bulk solution level sensor can cause cracks.

FDASep 16, 2019Nationwide• Abbott Gmbh & Co. KG Max-Planck-Ring 2 65205 Wiesbaden Germany

Draegar Medical Systems, Inc.: The Infinity Acute Care System (IACS) Monitoring Solution...

Cybersecurity vulnerabilities may cause device to reboot, lose alarm functionality, and/or lose communication with cockpit and/or the Infinity Network.

FDASep 13, 2019Nationwide• Draegar Medical Systems, Inc.

Integra LifeSciences Corp.: Cerelink ICP Monitor, Model Number 826820; intended for ...

There is a potential for a progressive decline in observed ICP readings of the monitor during use.

FDASep 12, 2019CA, CO, CT +8 more• Integra LifeSciences Corp.

Olympus Corporation of the Americas: Berkeley Disposa-Filter used with Berkeley VC-10 Vacuum C...

Berkeley Disposa-Filter may possess an insufficient ultrasonic weld defect which joins the two-halves of the filter cartridge, thus the housing could separate

FDASep 12, 2019Nationwide• Olympus Corporation of the Americas

Respironics California, LLC: Respironics RP-UI Assy, V60 Ventilators User Interface RP...

Ventilator touchscreen may become frozen and fail to respond to touch commands. If a patient requires a change in therapy, there is no warning associated with an unresponsive touchcreen, and therefore the clinician would have no prior indication of a touchscreen failure and would be unable to change ventilator settings. The ventilator will continue to function at the predetermined and accepted settings required to support the patient. A delay in therapy adjustments may result in hypercarbia and/or hypoxemia.

FDASep 11, 2019Nationwide• Respironics California, LLC

Pacific Medical Group Inc.: Loop-Style Tocotransducer (Nautilus) 2264LAX, that may ha...

Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent components that have not been appropriately verified or validated. Possible adverse clinical impact: inability to accurately detect and measure fetal heart rate, inability to accurately detect maternal peripheral oxygen saturation, inability to monitor uterine activity to follow contractions, inability to determine temperature, and maternal blood pressure, lack of electrocardiography tracing, patient/clinician burns, and delay in detecting maternal or fetal distress.

FDASep 11, 2019Nationwide• Pacific Medical Group Inc.

Pacific Medical Group Inc.: Toco+ transducer with ECG/IUP capability (wired), that ma...

Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent components that have not been appropriately verified or validated. Possible adverse clinical impact: inability to accurately detect and measure fetal heart rate, inability to accurately detect maternal peripheral oxygen saturation, inability to monitor uterine activity to follow contractions, inability to determine temperature, and maternal blood pressure, lack of electrocardiography tracing, patient/clinician burns, and delay in detecting maternal or fetal distress.

FDASep 11, 2019Nationwide• Pacific Medical Group Inc.

Mizuho America, Inc.: Microsurgical Operating Room Tables;7300B (18-350-70);

Unintended tilting of the Tabletop MST 7300BX and incorrect operation due to infrared operating signal errors of Tabletops MST 7300B and MST 7300BX.

FDASep 11, 2019AZ, CA, FL +6 more• Mizuho America, Inc.

Respironics California, LLC: Respironics V60 Ventilator, Service # 850008, REF: 105361...

Ventilator touchscreen may become frozen and fail to respond to touch commands. If a patient requires a change in therapy, there is no warning associated with an unresponsive touchscreen, and therefore the clinician would have no prior indication of a touchscreen failure and would be unable to change ventilator settings. The ventilator will continue to function at the predetermined and accepted settings required to support the patient. A delay in therapy adjustments may result in hypercarbia and/or hypoxemia.

FDASep 11, 2019Nationwide• Respironics California, LLC

Pacific Medical Group Inc.: Ultrasound Transducer (M1356A), that may have been servic...

Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent components that have not been appropriately verified or validated. Possible adverse clinical impact: inability to accurately detect and measure fetal heart rate, inability to accurately detect maternal peripheral oxygen saturation, inability to monitor uterine activity to follow contractions, inability to determine temperature, and maternal blood pressure, lack of electrocardiography tracing, patient/clinician burns, and delay in detecting maternal or fetal distress.

FDASep 11, 2019Nationwide• Pacific Medical Group Inc.

Respironics California, LLC: Respironics V680 Ventilator, Service # 850011, (OUS Only)

Ventilator touchscreen may become frozen and fail to respond to touch commands. If a patient requires a change in therapy, there is no warning associated with an unresponsive touchcreen, and therefore the clinician would have no prior indication of a touchscreen failure and would be unable to change ventilator settings. The ventilator will continue to function at the predetermined and accepted settings required to support the patient. A delay in therapy adjustments may result in hypercarbia and/or hypoxemia.

FDASep 11, 2019Nationwide• Respironics California, LLC

Pacific Medical Group Inc.: External Toco Transducer (M1355A), that may have been ser...

Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent components that have not been appropriately verified or validated. Possible adverse clinical impact: inability to accurately detect and measure fetal heart rate, inability to accurately detect maternal peripheral oxygen saturation, inability to monitor uterine activity to follow contractions, inability to determine temperature, and maternal blood pressure, lack of electrocardiography tracing, patient/clinician burns, and delay in detecting maternal or fetal distress.

FDASep 11, 2019Nationwide• Pacific Medical Group Inc.

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