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Showing 5061–5080 of 8389 results

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Aeris Balloon Dilation Catheter (Bryan Medical) – Mislabeling (2023)

Devices were mislabeled.

FDAMay 16, 2023Nationwide• Bryan Medical Inc

Draeger Softbed Resuscitaire (Draeger) – Weight Display Problem (2023)

The Resuscitaire Infant Radiant Warmer with the optional scale could display inaccurate weight values.

FDAMay 16, 2023Nationwide• Draeger Medical Systems, Inc.

HeartWare VAD System (Heartware) – Monitor Logfile Issue (2023)

Medtronic has identified that the logfiles downloaded from the recently updated Model 1521 monitors (Serial Numbers: MON4xxxxxx for OUS and MON5xxxxxx for US), are unable to be processed by the Autologs web portal.

Low

FDAMay 16, 2023Nationwide• Heartware, Inc.

OEC Elite Systems (GE OEC) – Image Intensifier Detachment (2023)

Image intensifiers on systems, used to provide fluoroscopic/digital spot images can become detached if the systems encounter a large impact force when moved, which may result in the image intensifier falling, which could lead to injuries such as fractures, hematoma, contusion, bruise, pain.

FDAMay 15, 2023Nationwide• GE OEC Medical Systems, Inc

OEC Flexiview 8800 Systems (GE OEC) – Image Intensifier Detachment (2023)

Image intensifiers on systems, used to provide fluoroscopic/digital spot images can become detached if the systems encounter a large impact force when moved, which may result in the image intensifier falling, which could lead to injuries such as fractures, hematoma, contusion, bruise, pain.

FDAMay 15, 2023Nationwide• GE OEC Medical Systems, Inc

Field Upgrade Kits (GE OEC) – Image Intensifier Detachment (2023)

Image intensifiers on systems, used to provide fluoroscopic/digital spot images can become detached if the systems encounter a large impact force when moved, which may result in the image intensifier falling, which could lead to injuries such as fractures, hematoma, contusion, bruise, pain.

FDAMay 15, 2023Nationwide• GE OEC Medical Systems, Inc

Philips Respironics V60 Ventilator (DRE Medical) – Gas Fitting Risk (2023)

Devices were imported with Japanese Language and NIST Oxygen Gas Fittings and retrofitted, may pose a serious health risk as the gas pathway of these devices may be contaminated.

FDAMay 15, 2023CA, FL• DRE Medical Group Inc

SPiN Drive Instruments (Olympus) – Navigation Tracking Malfunction (2023)

Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality during endobronchial procedures and prompts the system to report a coil break warning message. This could result in a potential procedural delay

FDAMay 15, 2023Nationwide• Olympus Corporation of the Americas

OEC 9900 Systems (GE OEC) – Image Intensifier Detachment (2023)

Image intensifiers on systems, used to provide fluoroscopic/digital spot images can become detached if the systems encounter a large impact force when moved, which may result in the image intensifier falling, which could lead to injuries such as fractures, hematoma, contusion, bruise, pain.

FDAMay 15, 2023Nationwide• GE OEC Medical Systems, Inc

OEC 9800 Systems (GE OEC) – Image Intensifier Detachment (2023)

Image intensifiers on systems, used to provide fluoroscopic/digital spot images can become detached if the systems encounter a large impact force when moved, which may result in the image intensifier falling, which could lead to injuries such as fractures, hematoma, contusion, bruise, pain.

FDAMay 15, 2023Nationwide• GE OEC Medical Systems, Inc

Procedural Kits (Medline) – Ultrasound Gel Sterility (2023)

Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

FDAMay 15, 2023Nationwide• MEDLINE INDUSTRIES, LP Northfield

NeuMoDx SARS-CoV-2 Assay (NeuMoDx) – Lot Number Discrepancy (2023)

Potential for lot number discrepancies between the test strip packaging and the barcode label applied to the test strip that is read by the instrument for LOT 123909 of NeuMoDx SARS-CoV-2 Test Strips (REF 300800). The instrument registers the non-human readable text as lot number 123910 from the barcode label.

FDAMay 15, 2023Nationwide• NeuMoDx Molecular Inc

Probe Cover Kits (Medline) – Ultrasound Gel Sterility (2023)

Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

FDAMay 15, 2023Nationwide• MEDLINE INDUSTRIES, LP Northfield

Icelock Ratchet (Ossur) – Mechanical Wear Risk (2023)

A mechanical lock used to connect and release a locking liner into a prosthetic socket have an attachment pin and lock that can wear down faster than expected, leading to the potential for the pin to disengage from the lock, leading to loss of suspension of the external prosthetic system that replaces a missing lower limb, which can lead to falling and injury.

FDAMay 12, 2023AL, AZ, AR +41 more• Ossur H F Grjothals 5 Reykjavik Iceland

TrackMaster Treadmill (Full Vision) – Drive PCB Malfunction (2023)

Treadmill malfunction: drive PCB can misread the signals and stop or reverse and then accelerate forward.

FDAMay 12, 2023Nationwide• Full Vision Inc

TrackMaster Treadmill (Full Vision) – Drive PCB Malfunction (2023)

Treadmill malfunction: drive PCB can misread the signals and stop or reverse and then accelerate forward.

FDAMay 12, 2023Nationwide• Full Vision Inc

Medline O.R. Scissors (Medline) – Sterility Compromise (2023)

The scissors were manufactured without a tip protector resulting in the scissors breaking through the semi-rigid plastic tray compromising sterility.

FDAMay 12, 2023Nationwide• MEDLINE INDUSTRIES, LP Northfield

TrackMaster Treadmill (Full Vision) – Drive PCB Malfunction (2023)

Treadmill malfunction: drive PCB can misread the signals and stop or reverse and then accelerate forward.

FDAMay 12, 2023Nationwide• Full Vision Inc

TrackMaster Treadmill (Full Vision) – Drive PCB Malfunction (2023)

Treadmill malfunction: drive PCB can misread the signals and stop or reverse and then accelerate forward.

FDAMay 12, 2023Nationwide• Full Vision Inc

Superion Instrument (Boston Scientific) – Implant Procedure Risk (2023)

Pending update to indirect decompression system instructions for use informing users that excessive force during the implant procedure may cause driver instrument tip breaks, which may result in metal fragments (Driver teeth/tips) within the implant location; and if metal fragments are not removed and remain in situ, MRI scans are NOT advised due to potential risk of patient injury.

FDAMay 12, 2023Nationwide• Boston Scientific Neuromodulation Corporation

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