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Showing 481–500 of 1781 results

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Siemens Medical Solutions USA, Inc: AXIOM MULTIX MP - Inended Radiographic X ray Table is a p...

Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire

FDAMay 31, 2024Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: AXIOM Vertix Solitaire - The Vertix MD Trauma has been sp...

Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire

FDAMay 31, 2024Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: ZE for Vertix Solitaire - The AXIOM Vertix Solitaire is a...

Fire/Burn Risk

Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire

FDAMay 31, 2024Nationwide• Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc: MULTIX TOP - Intended Use: The Multix TOP I PRO Radiograp...

Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire

FDAMay 31, 2024Nationwide• Siemens Medical Solutions USA, Inc

Howmedica Osteonics Corp.: Gray Revision Instrument System Accessory Tray/Case, Cata...

The design of the HRIS Storage & Sterilization Case and Tray P/N 6210-9-900 and the Gray Revision Instrument System Accessory Tray/Case P/N 6210-9-910 may lead to misuse of the Gray Revision Instruments including re-use and re-sterilization of the single-use, sterile-packaged instruments.

FDAMay 23, 2024Nationwide• Howmedica Osteonics Corp.

Howmedica Osteonics Corp.: HRIS Storage & Sterilization Case and Tray, Catalog/Part ...

The design of the HRIS Storage & Sterilization Case and Tray P/N 6210-9-900 and the Gray Revision Instrument System Accessory Tray/Case P/N 6210-9-910 may lead to misuse of the Gray Revision Instruments including re-use and re-sterilization of the single-use, sterile-packaged instruments.

FDAMay 23, 2024Nationwide• Howmedica Osteonics Corp.

Beckman Coulter, Inc.: DxI 9000 Access Immunoassay Analyzer, Catalog #C11137.

When a DxI 9000 Access Immunoassay Analyzer is connected to a Laboratory Automation System (LAS) and is running with the system software versions 1.17.0 and below, the analyzer does not send a message to the LAS when the sample wheel is full, and the LAS continues sending samples despite the limited capacity to process new samples. Therefore, sample tests may be aliquoted but not processed when the number of tests associated with onboard patient samples exceeds the throughput limit. If this issue occurs test results are flagged with a sample wheel timeout (SWT) error flag, and there may be a delay in reporting test results which could lead to a delay in patient treatment.

FDAMay 22, 2024Nationwide• Beckman Coulter, Inc.

Maquet Cardiovascular, LLC: The VASOVIEW HemoPro Endoscopic Vessel Harvesting Systems...

Potential for there to be a fluid ingress into the handle of the harvesting tool, which may lead to the device not providing cautery or providing cautery when not intended.

FDAMay 17, 2024Nationwide• Maquet Cardiovascular, LLC

Siemens Healthcare Diagnostics Inc: Software version 5.3 in: RAPIDPoint 500e Blood Gas Syste...

Siemens Healthineers has identified an issue with the RAPIDPoint500e system software version 5.3. This issue affects how the sample source is identified at the LIS when using the capillary mode. With this software version, samples run in the capillary mode are incorrectly labeled as arterial when displayed on the LIS, leading to the potential for results to be flagged according to an established arterial range. Capillary sample results are correctly identified as capillary on both the RAPIDPoint 500e system display and the instrument printouts. The issue only affects the new software version 5.3 and only capillary sample mode is impacted. The inability to distinguish specimen sources for blood gas may lead to incorrect diagnoses and management decisions.

FDAMay 17, 2024Nationwide• Siemens Healthcare Diagnostics Inc

Biomet, Inc.: RingLoc Bi-Polar Hip System Acetabular Cup, 41 mm Outer D...

41 mm acetabular outer heads were potentially assembled with a 42 mm locking ring, may lead to joint instability leading requiring surgical intervention

FDAMay 17, 2024Nationwide• Biomet, Inc.

Maquet Cardiovascular, LLC: The VASOVIEW HemoPro 2 Endoscopic Vessel Harvesting Syste...

Potential for there to be a fluid ingress into the handle of the harvesting tool, which may lead to the device not providing cautery or providing cautery when not intended.

FDAMay 17, 2024Nationwide• Maquet Cardiovascular, LLC

Inspire Medical Systems Inc.: Inspire Model 3028, IV Implantable Pulse Generator

There is a potential manufacturing defect which can lead to electrical leakage in the sensing circuit which causes a system malfunction and requires a revision surgery to replace the IPG,

FDAMay 16, 2024Nationwide• Inspire Medical Systems Inc.

Roche Diabetes Care, Inc.: Accu-Chek Guide (SC) Kit -Intended to quantitatively meas...

The reason for recall is the meters may show an incorrect measurement unit (mmol/L rather than mg/dL) and may result in the wrong unit of measure. Which may subsequently cause an error in interpreting a result as approximately 18 times lower that the actual blood glucose. Potential immediate health consequences of the glucose meter providing a reading in the wrong units of measurement (UOM) may result in inappropriate rescue therapy for presumed hypoglycemia including urgent and repeat administration of carbohydrates. This in turn could lead to frequent episodes of hyperglycemia which is unrecognized and undertreated.Long range consequences of continued use of the affected meters could include mismanagement of the patient s diabetes for longer periods of time potentially resulting in a major health event (in general persistent and/or severe hyperglycemia) that may lead them to seek medical attention, and depending on the duration of hyperglycemia, could contribute to the development of microvascular (i.e., retinopathy, neuropathy, nephropathy) and/or macrovascular (i.e., myocardial infarction, ischemic stroke) complications of diabetes and could lead to fetal damage (abnormal fetal growth and altered organ development and maturation, fetal hypoxemia, spontaneous abortion, and congenital anomalies) in pregnant women. This issue was identified by three initial consumer complaints, with reports that the meters were presenting the incorrect unit of measure.

FDAMay 13, 2024Nationwide• Roche Diabetes Care, Inc.

Medtronic Neuromodulation: Medtronic Ascenda Intrathecal Catheter, Models: a) 8780...

Design update to the Ascenda Intrathecal Catheter Models 8780, 8781, and 8784. The intent of the design update is to reduce the potential for tissue growth into the Ascenda catheter connector which may potentially lead to catheter occlusion.

FDAMay 10, 2024Nationwide• Medtronic Neuromodulation

Canon Medical System, USA, INC.: MRI systems: Vantage Orian MRT-1550 (MEXL-1550), Vantage ...

The terminal block used to secure the power supply cable for the gradient coil of the MRI system was not secured as designed, which could cause cable disconnection, which could lead to arcing, followed by melting of the cable, ignition, smoke, and fire.

FDAMay 10, 2024AL, AZ, AR +35 more• Canon Medical System, USA, INC.

Remote Diagnostic Technologies Ltd. Farnborough Aerospace Centre Aerospace Boulevard Farnborough United Kingdom: Philips Tempus LS-Manual Defibrillator, Part Number: 00-3...

Simultaneous ECG measurements with multiple devices, including a manual defibrillator, on the same patient may cause electrical noise or interference, which may lead to distortions of the ECG signal; distortions may lead to no or ineffective pacing, or no or inappropriate defibrillation pulse.

FDAMay 9, 2024Nationwide• Remote Diagnostic Technologies Ltd. Farnborough Aerospace Centre Aerospace Boulevard Farnborough United Kingdom

Echonous Inc: Kosmos on iOS impacting iOS, Model Numbers: P007639, P007...

Ultrasound system has a bug in affected iOS software, which after DICOM export, can cause inaccuracy in postprocessed measurements done in 3rd party software, such as PACS or other post-processing software, which may lead to inaccurate diagnoses or treatment.

FDAMay 9, 2024AL, AK, AZ +29 more• Echonous Inc

Thoratec Corp.: Thoratec HeartMate System Monitor, REF: 1286, L1286, 1286...

System monitor screen may display atypical behavior: Overlapping screens/buttons, Frozen screen, Distorted text, blanks, or zeroes in place of values, Unresponsive buttons where the user is unable to initiate a command, which may lead to anxiety /inconvenience, hemodynamic compromise, extended surgical time, and Pump Stop command may be selected

FDAMay 8, 2024Nationwide• Thoratec Corp.

Becton, Dickinson and Company, BD Biosciences: BD Multitest 6-Color TBNK CE-IVD, REF: 644611; BD Multite...

Multitest with compromised raw material used to assess immune system status may result in flow cytometry plot with unusual staining pattern, nonspecific aggregates, high background, double positive event increase on CD3+CD4+vsCD3+CD8+ and/or CD3-CD16+CD56+vsCD3-CD19+, contaminated antibodies, may lead to erroneous or delayed results, additional patient sample, might impact healthcare decisions

FDAMay 8, 2024AL, AR, CA +31 more• Becton, Dickinson and Company, BD Biosciences

Integra LifeSciences Corp.: CODMAN EVD BACTISEAL 1.9mm I.D. Catheter Set- indicated f...

Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal may compromise the product sterility.

FDAMay 7, 2024Nationwide• Integra LifeSciences Corp.

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