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Showing 7621–7640 of 8389 results

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Boston Scientific Corporation: VICI RDS VENOUS STENT System Product Usage: is indicated...

The firm has received reports of stent migration after implantation

FDAApr 12, 2021Nationwide• Boston Scientific Corporation

INNOVA MEDICAL GROUP, INC.: For In Vitro Diagnostic Use Only *** 25T 888 SARS-CoV-2 A...

Due to distributing test kits to customers who were not part of a clinical investigation.

FDAApr 9, 2021Nationwide• INNOVA MEDICAL GROUP, INC.

INNOVA MEDICAL GROUP, INC.: COVID-19 Self-Test Kit * INNOVA * 7T

Due to distributing test kits to customers who were not part of a clinical investigation.

FDAApr 9, 2021Nationwide• INNOVA MEDICAL GROUP, INC.

Roche Diagnostics Operations, Inc.: Elecsys Troponin I Immunoassay: Catalog# 05094810160 - Pr...

Recall reason is possible sporadic false negative conventional troponin results. Roche has confirmed an issue with running Elecsys Troponin I/Troponin I STAT and Elecsys proBNP II/proBNP II STAT on the cobas e 601 and 602 modules. When the proBNP II analyte is measured immediately before the Troponin I analyte on the same module, a decreased recovery on Troponin I was observed.

FDAApr 7, 2021Nationwide• Roche Diagnostics Operations, Inc.

Roche Diagnostics Operations, Inc.: Elecsys Troponin I STAT Immunoassay: Catalog# 05094798160...

Recall reason is possible sporadic false negative conventional troponin results. Roche has confirmed an issue with running Elecsys Troponin I/Troponin I STAT and Elecsys proBNP II/proBNP II STAT on the cobas e 601 and 602 modules. When the proBNP II analyte is measured immediately before the Troponin I analyte on the same module, a decreased recovery on Troponin I was observed.

FDAApr 7, 2021Nationwide• Roche Diagnostics Operations, Inc.

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): CareLink SmartSync Device Manager (24970A). used to inte...

There is a SmartSync software issue that results in an overestimation in the displayed longevity of these devices during an approximate 6-month window of time before the device triggers its Recommended Replacement Time (RRT).

FDAApr 6, 2021Nationwide• Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): Implantable Pulse Generators - Product Usage: used to tre...

A longevity estimation error may occur in the early years of device life when a unipolar pacing vector is programmed in the right atrial (RA) lead and/or the right ventricular (RV) lead. No other device features or therapies are impacted.

FDAApr 6, 2021Nationwide• Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): CareLink SmartSync Device Manager - Product Usage: used t...

A longevity estimation error may occur in the early years of device life when a unipolar pacing vector is programmed in the right atrial (RA) lead and/or the right ventricular (RV) lead. No other device features or therapies are impacted.

FDAApr 6, 2021Nationwide• Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): Implantable cardiac resynchronization therapy pacemakers ...

A longevity estimation error may occur in the early years of device life when a unipolar pacing vector is programmed in the right atrial (RA) lead and/or the right ventricular (RV) lead. No other device features or therapies are impacted.

FDAApr 6, 2021Nationwide• Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): Programmers - Product Usage: used to treat arrhythmias re...

A longevity estimation error may occur in the early years of device life when a unipolar pacing vector is programmed in the right atrial (RA) lead and/or the right ventricular (RV) lead. No other device features or therapies are impacted.

FDAApr 6, 2021Nationwide• Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): CRT-P Quad Models (CRT-Ps): a. Percepta CRT-P MRI: W1TR01...

There is a SmartSync software issue that results in an overestimation in the displayed longevity of these devices during an approximate 6-month window of time before the device triggers its Recommended Replacement Time (RRT).

FDAApr 6, 2021Nationwide• Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Merits Holdings Co. dba Merits Health Products, Inc.: Power Wheelchair

Seat baseplate pin has broken in the field.

FDAApr 1, 2021Nationwide• Merits Holdings Co. dba Merits Health Products, Inc.

Merits Holdings Co. dba Merits Health Products, Inc.: Scooter

Seat baseplate pin has broken in the field.

FDAApr 1, 2021Nationwide• Merits Holdings Co. dba Merits Health Products, Inc.

Philips North America Llc: Philips Xper Flex Cardio (FC2010, Procedure Room and FC20...

Performance issues with the Xper Flex Cardio Physio Monitoring System include: potential delay of up to 10 seconds in displaying ECG, invasive blood pressure and other parameters; patient weight is rounded to the nearest whole kilogram;Xper IM software used with the Xper Flex Cardio Physio Monitoring System may periodically crash; No SpO2 numeric or plethysmography is displayed when SpO2 is connected o the Flex Cardio device; display of certain data from the FC2010 becomes frozen, i.e., waveforms cease sweeping and updating and the ECG, IBP, and respiration numeric values cease to update;e ECG, IBP, and respiration waveforms become flat lines and no audible alarms are produced for HR and IBP, upon start up, an unexpected non physiological ECG waveform, erratic heart rate numeric value, and non-physiological display of any other active waveforms may appear on the Boom Monitor

FDAMar 29, 2021Nationwide• Philips North America Llc

Siemens Medical Solutions USA, Inc: Artis zee ceiling-interventional Fluoroscopic X-Ray Syste...

Some Artis zee ceiling systems show an increased abrasion of the cabling at the cable outlet of the inner C-arm, the limited functionality may not be sufficient to continue with treatment as planned. This may result in a situation where it is necessary to cancel clinical treatment or to continue treatment on an alternative system.

FDAMar 26, 2021Nationwide• Siemens Medical Solutions USA, Inc

Infusion Pump Repair: Alaris Pump Module, Model 8100, serviced/repaired by Infu...

Bezel repair parts used, not by the original manufacturer, to service and repair infusion pump modules, may over time experience cracking or separation of the posts from the bezel. The separation of one or more bezel repair part posts may result in free flow, over infusion, under infusion or interruption of infusion.

FDAMar 26, 2021CA• Infusion Pump Repair

RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden: RayStation Model Number: (9A)9.0.0.113, 9B (9.1.0.933), 9...

Flags edited in RayCare after a patient has been checked in may not always be updated in RayTreat.

FDAMar 25, 2021Nationwide• RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden

Medtronic Neuromodulation: Intellis Model 97755 Recharger - Product Usage: designed ...

There is a potential for unintended heating that can occur with the Intellis Model 97755 Recharger.

FDAMar 25, 2021Nationwide• Medtronic Neuromodulation

The Biomed Guys: Alaris Infusion Pump Module, Model 8100, serviced/repaire...

Bezel repair part, not by the original manufacturer, used in the service and repair of Alaris Pump Module Model 8100, may experience cracking and/or separation of the bezel posts. Separation of one or more bezel posts could lead to free flow, over infusion, under infusion, or interruption of infusion.

FDAMar 25, 2021IN, TX• The Biomed Guys

Roche Molecular Systems, Inc.: cobas Liat Analyzer: respiratory virus panel nucleic acid...

Invalid or false positive results for one or more targets (SARS-CoV-2/Influenza A/Influenza B) using the cobas SARS-CoV-2 & Influenza A/B assay for use under emergency use authorization on the cobas Liat analyzer, showed abnormal PCR growth curves

FDAMar 25, 2021Nationwide• Roche Molecular Systems, Inc.

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