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Showing 8021–8040 of 11714 results

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Ingenia Elition X MR System (Philips) – Gradient Coil Fire Risk (2022)

Gradient Coil may act as a heat source with a potential to produce smoke and/or fire.

FDANov 22, 2022Nationwide• Philips North America Llc

MR 7700 System Upgrade (Philips) – Gradient Coil Fire Risk (2022)

Gradient Coil may act as a heat source with a potential to produce smoke and/or fire.

FDANov 22, 2022Nationwide• Philips North America Llc

MR 7700 System (Philips) – Gradient Coil Fire Risk (2022)

Fire/Burn Risk

Gradient Coil may act as a heat source with a potential to produce smoke and/or fire.

High

FDANov 22, 2022Nationwide• Philips North America Llc

SmartPath to Elition X (Philips) – Gradient Coil Fire Risk (2022)

Gradient Coil may act as a heat source with a potential to produce smoke and/or fire.

FDANov 22, 2022Nationwide• Philips North America Llc

Specific Protein Control (Randox) – Rheumatoid Factor Decrease (2022)

Concentration of Rheumatoid Factor has decreased in Specific Protein Control Level 1-3 causing delay in reporting results due to Quality Controls running low outside range

FDANov 22, 2022Nationwide• Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland

Sodium Chloride Injection (Fresenius) – Sterility Concern (2022)

Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline Solution.

Class IIModerate

FDANov 22, 2022Nationwide• Fresenius Medical Care Holdings, Inc.

Guardian Glucose Monitoring App (Medtronic) – Logout Issue (2022)

An app, part of a continuous glucose monitoring system, for use with smartphone devices may automatically log out from CareLink, then the app is not able to upload data. When logged out, linked care partners will not receive SMS notifications (could result in hypoglycemia or hyperglycemia), and sensor glucose values will also not be sent to the InPen app.

FDANov 21, 2022Nationwide• Medtronic MiniMed

Proveo 8 Microscope (Leica) – Power Supply Overheat (2022)

There is a potential issue resulting in the Power Supply potentially becoming overheated due to internal components overstressing. Consequently, due to the overstressing of the internal components, one specific component can fail which will cause the device to unexpectedly shutdown.

FDANov 21, 2022Nationwide• Leica Microsystems, Inc.

BBL Chocolate II Agar (Becton Dickinson) – Nutrient Concentration Issue (2022)

Boxes contain a reduced concentration of Nicotinamide Adenine Dinucleotide and does not provide enough of the blood factors necessary to support Haemophilus growth. The reduction could cause a false negative result for Haemophilus isolation in a clinical specimen.

FDANov 21, 2022Nationwide• Becton Dickinson & Co.

Fetal Spiral Electrode (Philips) – Tip Breaking Risk (2022)

Fetal Spiral Electrode (FSE) spiral tip of the FSE breaking off during use and requiring surgical intervention to remove the broken tip from the neonate patient. Philips has decided to discontinue the distribution of this product.

FDANov 21, 2022Nationwide• Philips North America Llc

Provido Microscope (Leica) – Power Supply Overheat (2022)

There is a potential issue resulting in the Power Supply potentially becoming overheated due to internal components overstressing. Consequently, due to the overstressing of the internal components, one specific component can fail which will cause the device to unexpectedly shutdown.

FDANov 21, 2022Nationwide• Leica Microsystems, Inc.

M530 OHX Microscope (Leica) – Power Supply Overheat (2022)

There is a potential issue resulting in the Power Supply potentially becoming overheated due to internal components overstressing. Consequently, due to the overstressing of the internal components, one specific component can fail which will cause the device to unexpectedly shutdown.

FDANov 21, 2022Nationwide• Leica Microsystems, Inc.

Ventana PD-L1 Assay (Ventana) – Light Staining Issue (2022)

Internal comparison studies revealed unacceptable, light staining. Light staining affects the borderline of positive versus negative test results. It can cause a reduction in both staining intensity and the percent positivity, which could potentially lead to a false-negative PD-L1 result.

FDANov 18, 2022Nationwide• Ventana Medical Systems, Inc.

IRISpec Control (Beckman Coulter) – False Positive Results (2022)

Beckman Coulter has become aware of an increase in customer complaints generated for intermittent IRISpec CB glucose control false positive results when used in conjunction with iChemVelocity Urine Chemistry Strips PN 800-7212

FDANov 18, 2022PR• Beckman Coulter, Inc.

Medline CISION Sterile Blades (Medline) – Sterile Packaging Breach (2022)

Potential of the blade puncturing the outer foil layer causing a breach in the sterile packaging.

FDANov 18, 2022Nationwide• MEDLINE INDUSTRIES, LP Northfield

4Kscore Test (BioReference) – Software Anomalies (2022)

SPM software anomalies that may lead to the generation of erroneous 4Kscore Test results

FDANov 18, 2022Nationwide• BioReference Health, LLC

Electrosurgical Suction Coagulator (ConMed) – Suction Port Occlusion (2022)

Suction ports may potentially be occluded on the affected devices. If this occurs, the affected devices will not be able to perform the suction function during use, which could cause a delay in procedure and could require another device to be used.

FDANov 18, 2022Nationwide• ConMed Corporation

Presource IV Start Kit (Cardinal Health) – Connector Defect (2022)

Presource Kits contains the ICU MicroClave Clear Connector due to a manufacturing defect there is a gap between the connectors top and bottom housings which may lead to fluid leaks and loss of fluid path integrity

FDANov 18, 2022Nationwide• Cardinal Health 200, LLC

Natus Cranial Access Kit (Natus) – Recalled Surgical Drapes (2022)

Due to Cranial Access Kits containing recalled sterile surgical drapes. The sterile surgical drapes are being recalled due to the liner on the adhesive component is difficult to remove without damaging the product and may render the product unusable.

FDANov 18, 2022Nationwide• Natus Medical Incorporated

DeVilbiss Oxygen Concentrator (DeVilbiss) – Overheating Risk (2022)

The firm has received complaints of the device becoming hot. The firm has updated the user manual to include warnings that applied parts in contact with the patient may in some situations exceed 41 degrees Celsius (105.8 degrees Fahrenheit), clarification on expected service life, and the need for maintenance to certain components.

FDANov 18, 2022Nationwide• DeVilbiss Healthcare LLC

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