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Medical device and health technology recalls from FDA. Includes diagnostic equipment, implants, monitors, and therapeutic devices.
Performance concerns for the CMV IgM analyte. Analyte has demonstrated variable elevated background depending on the handling of the reagent pack.
The pump may have a welding defect that can lead the pump to malfunction. The issue is under investigation by the firm. It is suspected that a weld defect on the center post cap may allow moisture into the center post and corrode the magnets that keep the impeller rotating concentrically, leading to unintended contact between the center post and impeller. If this occurs, it may affect blood flow through the pump. The issue may present clinical signs and symptoms that resemble pump thrombosis.
Verification of installation not documented or may be incomplete, could result in harm to the user such as skin burns, smoke inhalation, electric shock, or a crush or pinch injury or slip and fall injury. May lead to a patient procedural delay and/or infection
Lots incompatible with Test Definition (TDef) Version 1.4, potentially lead to the generation of erroneous total T3 results
Verification of installation not documented or may be incomplete, could result in harm to the user such as skin burns, smoke inhalation, electric shock, or a crush or pinch injury or slip and fall injury. May lead to a patient procedural delay and/or infection
Lots incompatible with Test Definition (TDef) Version 1.4, potentially lead to the generation of erroneous total T3 results
Siemens has become aware of three potential software issues with AXIOM Sensis or Sensis/ Sensis Lite systems. This may lead to a hazardous situation for patients if treatment cannot be continued on the system and treatment needs to be continued on an alternate system.
Telemetry error that may occur with Medtronic Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds).
Telemetry error that may occur with Medtronic Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds).
if the protective earth is interrupted and an additional fault leads to a fault current, the detection of the fault current may not be ensured may cause an electric shock if a person is in contact with metallic parts of the Carm
Reports received of torn corrugated breathing tubes.
if the protective earth is interrupted and an additional fault leads to a fault current, the detection of the fault current may not be ensured may cause an electric shock if a person is in contact with metallic parts of the Carm
Reports received of torn corrugated breathing tubes.
Firm distributed tests which have not been cleared or authorized for marketing or distribution in the United States.
Firm distributed tests which have not been cleared or authorized for marketing or distribution in the United States.
Arterial Blood Sampler sterility cannot be guaranteed throughout the shelf life of the product.
Variable and out of specification QC results with HemosIL ReadiPlasTin. IL will remove all lots from the market and convert customers to an alternative prothrombin time (PT) reagent, specifically HemosIL RecombiPlasTin 2G.
DePuy Synthes Radial Head Replacement System Contraindications added to Electronic Instructions for Use (e-IFU): Absolute contraindications include: Infection, sepsis, osteomyelitis.
Product found to not comply to Class 1 Laser safety requirement.
The problem is with the Bio-Rad VARIANT nbs Sickle Cell Program Resin Update CD-ROM software; Model Number: 250-3020, included in VARIANT nbs Sickle Cell Progam Reorder Pack #250-3000. This CD-ROM software included in specific lots of VARIANT nbs Sickle Cell Progam Reorder Pack causes all customized settings in the Setup/Test/Data Setup subscreen and Setup/Test/Pattern Setting subscreen to be overwritten with the default settings when the Update Kit procedure is performed.The VARIANTnbs Sickle Cell Program has been validated using the default Resin Update CDROM parameters for the intended use. However, there is a risk that the customer's custom pattern settings may be different than the default settings, resulting in a different pattern being assigned to some samples that the laboratory has validated. Following the complaints from 4 customers who experienced these issues, the firm initiated this recall.