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Showing 6961–6980 of 8389 results

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Liko Universal Twinbar (Baxter) – incorrect center bolt (2022)

An incorrect center bolt was used in the assembly of the product which could result in a patient fall during use.

FDAFeb 21, 2022Nationwide• Baxter Healthcare Corporation

Gammex Non-Latex Surgical Gloves (Ansell) – border inspection failure (2022)

Transport company failed to stop at the border for required FDA inspection.

FDAFeb 19, 2022AZ, CA, NV +3 more• Ansell Healthcare Products LLC

SIGNA Excite HD (GE Healthcare) – image flipping risk (2022)

There is potential for the images to be flipped left to right.

FDAFeb 18, 2022Nationwide• GE Healthcare, LLC

Signa 1.5T TwinSpeed (GE Healthcare) – image flipping risk (2022)

There is potential for the images to be flipped left to right.

FDAFeb 18, 2022Nationwide• GE Healthcare, LLC

ORAcollect Dx (DNA Genotek) – liquid evaporation issue (2022)

Evaporation of stabilizing liquid reducing shelf life.

FDAFeb 18, 2022Nationwide• DNA Genotek Inc. 3000-500 Palladium Dr Kanata Canada

Cardiohelp-i Transport Guard (Maquet) – locking mechanism risk (2022)

Potential for a loose cylindrical pin on the Transport Guard that may result in the jamming of the locking mechanism causing the Transport Guard to not open or, if the locking pin is fully disengaged from the assembly, a full disassembly of the Transport Guard may occur, resulting in a delay of support if a product exchange is necessary.

FDAFeb 18, 2022Nationwide• Maquet Medical Systems USA

SIGNA HDx/HDxt (GE Healthcare) – image flipping risk (2022)

There is potential for the images to be flipped left to right.

FDAFeb 18, 2022Nationwide• GE Healthcare, LLC

NeuMoDx Cartridge (NeuMoDx) – SARS-CoV-2 false positive (2022)

Potential for false positive results for SARS-CoV-2 in identified lots of cartridges, when used in conjunction with assays containing SARS-CoV-2 targets (NeuMoDx" SARS-CoV-2 Test Strip Cat #300800 and NeuMoDx" Flu A-B/RSV/SARS-CoV-2 Vantage Assay Cat #300900) result incorrect management of patients

FDAFeb 18, 2022Nationwide• NeuMoDx Molecular Inc

SIGNA Excite 3T (GE Healthcare) – image flipping risk (2022)

There is potential for the images to be flipped left to right.

FDAFeb 18, 2022Nationwide• GE Healthcare, LLC

ORAcollect RNA (DNA Genotek) – liquid evaporation issue (2022)

Evaporation of stabilizing liquid reducing shelf life.

FDAFeb 18, 2022Nationwide• DNA Genotek Inc. 3000-500 Palladium Dr Kanata Canada

Medical Devices (Dollar Tree) – rodent exposure risk (2022)

Potential exposure to rodents and rodent activity in the distribution center.

FDAFeb 18, 2022Nationwide• Dollar Tree Distribution, Inc.

IRISpec Control (Beckman Coulter) – glucose test failure (2022)

IRISpec CA failures for glucose.

FDAFeb 16, 2022Nationwide• Beckman Coulter, Inc.

Revogene (Meridian) – false positive risk (2022)

The photomultiplier tube, may have compromised functionality in some instruments. As a result, the user is likely to observe an increase in false-positive or indeterminate results.

FDAFeb 15, 2022Nationwide• Meridian Bioscience Inc

VERIGENE Nucleic Acid Test Kit (Luminex) – control failure (2022)

Higher than normal "No Call Internal Control failures" due to a missing reagent within a small subset of the extraction tray lot.

FDAFeb 15, 2022Nationwide• Luminex Corporation

ProteusPLUS (Ion Beam) – proton beam pause verification (2022)

When resuming from a beam pause, the Proton Therapy System does not verify whether the beam range has not been manually modified during the pause and is still the prescribed one. Therefore, if an operator manually modified the range during a pause, there is a risk that a portion of the treatment beam after the resume is delivered with an error in range

FDAFeb 15, 2022FL, IL, KS +9 more• Ion Beam Applications S.A. Chemin Du Cyclotron 3 Louvain-la-neuve Belgium

Compella Bariatric Bed (Baxter) – power cord risk (2022)

Potential damage to the power cord may cause the power conductors to be exposed, thereby creating a risk of shock from the power mains.

FDAFeb 14, 2022Nationwide• Baxter Healthcare Corporation

Compella Therapy Air Supply Unit (Baxter) – power cord risk (2022)

Potential damage to the power cord may cause the power conductors to be exposed, thereby creating a risk of shock from the power mains.

FDAFeb 14, 2022Nationwide• Baxter Healthcare Corporation

CombiDiagnost R90 1.0 (Philips Medical) – Patient Data Overlap (2022)

While performing a fluoroscopy examination, there is a potential that the Radio Fluoroscopy (RF) viewer will also display a previous patient's radiography images. If the issue occurs, there will be differences in image content, image format and image size.

FDAFeb 11, 2022Nationwide• PHILIPS MEDICAL SYSTEMS

RayStation/RayPlan (RaySearch) – dose calculation error (2022)

Incorrect source to skin or surface distance (SSD) calculation may result in dose error when using RayStation system.

FDAFeb 11, 2022Nationwide• RaySearch America Inc

CombiDiagnost R90 1.1 (Philips Medical) – Patient Data Overlap (2022)

While performing a fluoroscopy examination, there is a potential that the Radio Fluoroscopy (RF) viewer will also display a previous patient's radiography images. If the issue occurs, there will be differences in image content, image format and image size.

FDAFeb 11, 2022Nationwide• PHILIPS MEDICAL SYSTEMS

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