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Showing 2101–2120 of 8389 results

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Smaxel CO2 Laser (IDS) – Certification Labeling Issue (2024)

The Smaxel Fractional CO2 Laser does not include a Certification label, and adequate instructions for safe operation of the device.

FDAOct 16, 2024Nationwide• IDS LTD 194 Simgung-Ro Gwangtan-Myeon Paju Korea (the Republic of)

Tandem Bipolar Shell (Smith & Nephew) – Retaining Ring Size (2024)

The Bipolar assembly contains an oversized Retainer Ring.

FDAOct 15, 2024Nationwide• Smith & Nephew, Inc.

Medline Open Heart CDS (Medline) – Incorrect Suture Package (2024)

Some of the suture packages within the convenience kits contain the incorrect needle type/size and suture diameter/length.

Moderate

FDAOct 15, 2024Nationwide• MEDLINE INDUSTRIES, LP Northfield

Draeger Atlan Anesthesia Workstation (Draeger) – Ventilation Failure (2024)

The Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.

FDAOct 15, 2024Nationwide• Draeger Medical, Inc.

Alcon Custom-Pak Constellation (Alcon) – Tubing Breakage (2024)

Reported breakage in the tubing Anti-Reflux Valve (ARV) due to improper use. As a result, changes to labeling were made.

FDAOct 15, 2024DE, IL, OK• Alcon Research LLC

Medline Shoulder Repair Pack (Medline) – Incorrect Suture Package (2024)

Some of the suture packages within the convenience kits contain the incorrect needle type/size and suture diameter/length.

FDAOct 15, 2024Nationwide• MEDLINE INDUSTRIES, LP Northfield

Medline Pacer Implant Pack (Medline) – Incorrect Suture Package (2024)

Some of the suture packages within the convenience kits contain the incorrect needle type/size and suture diameter/length.

FDAOct 15, 2024Nationwide• MEDLINE INDUSTRIES, LP Northfield

OrganOx Metra (Unknown) – Battery Cell Damage (2024)

Battery movement led to damage of one of the battery cells causing it to short to the battery retention bracket

FDAOct 15, 2024CA, FL, GA +8 more

Cook CTO Micro Wire Guide (Cook) – Incorrect Expiration Date (2024)

Devices from the affected device lots have labels that state the incorrect expiration dates.

FDAOct 14, 2024Nationwide• Cook Incorporated

Defibtech Pediatric Defibrillation Pads (Defibtech) – Labeling Issue (2024)

Within the Irish Market, that a Field Safety Notice is being issued due to a select number of authorized labelled Defibtech AED Pads, which have had the authorized label removed and an unauthorized label applied, could potentially lead to expired Defibtech AED Pads appearing as though they are within the acceptable shelf life.there is a possibility of hydrogel drying, which may result in poor electrical connection to the patient, which can reduce the energy delivered to the patient

FDAOct 14, 2024Nationwide• Defibtech, LLC

Defibtech Pediatric Defibrillation Pads (Defibtech) – Labeling Issue (2024)

Within the Irish Market, that a Field Safety Notice is being issued due to a select number of authorized labelled Defibtech AED Pads, which have had the authorized label removed and an unauthorized label applied, could potentially lead to expired Defibtech AED Pads appearing as though they are within the acceptable shelf life.there is a possibility of hydrogel drying, which may result in poor electrical connection to the patient, which can reduce the energy delivered to the patient

FDAOct 14, 2024Nationwide• Defibtech, LLC

Defibtech Adult Defibrillation Pads (Defibtech) – Labeling Issue (2024)

Within the Irish Market, that a Field Safety Notice is being issued due to a select number of authorized labelled Defibtech AED Pads, which have had the authorized label removed and an unauthorized label applied, could potentially lead to expired Defibtech AED Pads appearing as though they are within the acceptable shelf life.there is a possibility of hydrogel drying, which may result in poor electrical connection to the patient, which can reduce the energy delivered to the patient

FDAOct 14, 2024Nationwide• Defibtech, LLC

Defibtech Adult Defibrillation Pads (Defibtech) – Labeling Issue (2024)

Within the Irish Market, a Field Safety Notice is being issued due to a select number of authorized labelled Defibtech AED Pads, which have had the authorized label removed and an unauthorized label applied, could lead to expired Defibtech AED Pads appearing as though they are within the acceptable shelf life. There is a possibility of hydrogel drying, which may result in poor electrical connection to the patient, which can reduce the energy delivered to the patient.

FDAOct 14, 2024Nationwide• Defibtech, LLC

Welch Allyn Cardiology Suite (Baxter) – File ID Duplication (2024)

There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system receiving the DICOM file (e.g., Picture Archiving and Communication System (PACS)) relies solely on the UID to accept exams, this could lead to a mismatch of the patients identification with their physiological data.

FDAOct 11, 2024Nationwide• Baxter Healthcare Corporation

Welch Allyn XScribe System (Baxter) – File ID Duplication (2024)

There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system receiving the DICOM file (e.g., Picture Archiving and Communication System (PACS)) relies solely on the UID to accept exams, this could lead to a mismatch of the patients identification with their physiological data.

FDAOct 11, 2024Nationwide• Baxter Healthcare Corporation

Welch Allyn RScribe ECG System (Baxter) – File ID Duplication (2024)

There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system receiving the DICOM file (e.g., Picture Archiving and Communication System (PACS)) relies solely on the UID to accept exams, this could lead to a mismatch of the patients identification with their physiological data.

FDAOct 11, 2024Nationwide• Baxter Healthcare Corporation

Welch Allyn HScribe Holter System (Baxter) – File ID Duplication (2024)

There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system receiving the DICOM file (e.g., Picture Archiving and Communication System (PACS)) relies solely on the UID to accept exams, this could lead to a mismatch of the patients identification with their physiological data.

FDAOct 11, 2024Nationwide• Baxter Healthcare Corporation

VITROS CRP Slides (Ortho-Clinical) – Result Bias Issue (2024)

May Generate Negatively Biased Results When Testing Samples with High Concentrations of CRP, showing less than upper AMI of 90 mg/L (in the 70-90 mg/L range) while the samples having higher than 90 mg/L. User no way to know if the sample has to be diluted to measure again.

FDAOct 11, 2024Nationwide• Ortho-Clinical Diagnostics, Inc.

Welch Allyn Q-Stress System (Baxter) – File ID Duplication (2024)

There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system receiving the DICOM file (e.g., Picture Archiving and Communication System (PACS)) relies solely on the UID to accept exams, this could lead to a mismatch of the patients identification with their physiological data.

FDAOct 11, 2024Nationwide• Baxter Healthcare Corporation

Welch Allyn Vision Express System (Baxter) – File ID Duplication (2024)

There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system receiving the DICOM file (e.g., Picture Archiving and Communication System (PACS)) relies solely on the UID to accept exams, this could lead to a mismatch of the patients identification with their physiological data.

FDAOct 11, 2024Nationwide• Baxter Healthcare Corporation

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