Diamedix Is-EBV-EA-D IgG Enzyme Immunoassay Test Kit for In Vitro Diagnostic Use Catalog No. 720-640
Diamedix
Class I - Dangerous
Contains a gel-like contaminant that may affect product performance.
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Diagnostic Equipment
🏥 Medical Devices • 6,627 recalls
Class I - Dangerous
Underfilled reagent well that could lead to incorrect results
Class I - Dangerous
There is a potential for the knob assembly in the swivel adapter to fracture/break during use.
Several complaints were received for invalid calibration with low calibrator S1 while using VIDAS LH. Internal tests confirmed a decrease of the strips signal overtime for specific lots.
Class I - Dangerous
The solenoid plunger tip length is too short resulting in insufficient engagement to the Universal Loader enclosure to lock during use.
Class I - Dangerous
The device is not suitable for the control of the Troponin T assay due to unacceptable variation between vials. The deviation in precision observed is up to 28%. IQC that is reported as out of range could lead to a delay in reporting Troponin T results. If the failure occurs the operator may observe the quality control result for Troponin T falling outside range and/or increased imprecision for Quality Control monitoring.
Class I - Dangerous
There is a potential for the knob assembly in the swivel adapter to fracture/break during use.
Class I - Dangerous
An improper wiring connection on the chiller assembly may result in overheating of the connection and potential failure of certain components in the system.
The diameter of the drill sleeve guide raw material was found to be under tolerance, potentially resulting in the drill bit seizing in the guide during surgery.
Class I - Dangerous
The placing of weight on the VRAD detector, of the Brivo XR385 digital radiographic system, can introduce image artifacts, which can result in patient exam retakes.
AXIOM Artis with Laird Cooling Unit for SSFD: Material # 7555118. Artis is an angiography system developed for single and biplane diagnostic imaging and interventional procedures.
Siemens Medical Solutions USA
Class I - Dangerous
Due to a defective sealing, coolant may inflow into the electrical parts of the system cabinet, which could cause a short circuit and cause the system to shut down suddenly during an ongoing procedure
Artis zee systems with Laird Cooling Unit for SSFD: Material # 7555118. Artis is an angiography system developed for single and biplane diagnostic imaging and interventional procedures.
Siemens Medical Solutions USA
Class I - Dangerous
Due to a defective sealing, coolant may inflow into the electrical parts of the system cabinet, which could cause a short circuit and cause the system to shut down suddenly during an ongoing procedure
The firm has learned that some RayStation/RayPlan users have commissioned machines with erroneous Beam profile correction parameters. These parameters affect the dose calculated in corners of large or off-axis fields. This effect cannot be seen in the Beam Commissioning module and dose in large or off-axis fields needs to be validated using the Beam 3D Modeling module in RayPhysics/RayPlan Physics. The user must be aware to avoid incorrect dose calculations during treatment planning.
Discrepant results have been reported in patients with severe microcytic anemia (e.g.iron deficiency, thalassemia) and the following parameters are affected: RBC (red blood cell count), HGB (hemoglobin concentration), MCH (mean corpuscular hemoglobin), HCT (hematocrit), and MCV (mean corpuscular volume).
The connector of the power supply was capable of fitting other components provided with the system. However, the voltage output of the reader power supply is incompatible with the other component and, if incorrectly connected, could result in irreparable damage to the system.
The block used to connect the patient pallet to the couch may be assembled incorrectly. A screw may be misaligned in the patient pallet.
The stainless steel belt which runs the length of the table underneath the tabletop is exposed when the tabletop is extended into the magnet for scanning. The firm has received two complaints where technologists have cut their fingers on this belt.
Medtronic has become aware that certain lots of the VCLAS 3MM, 10MM, and 15MM laser diffusing fibers were not tested at intended laser power levels, due to an issue related to calibration of the test equipment, which can lead to the potential for low laser energy output from fiber or fiber burnout at lower wattage.
Certain VOLISTA StandOP Surgical Lights have been identified as having a potential light head detachment issue. Improper assembly of the bracket that connects the light head to the axle fork could result in the light head bracket breaking, causing the light head to detach from the arm and become suspended only from the cabling inside the arm. Use of an affected device may result in serious injury to patient and/or medical staff if the light head detaches and drops, impacting patient and/or medical staff during demonstration, service, or use.
Possible diminished performance prior to its established expiration date.