Medical equipment, implants, and diagnostic devices
Dental EZ Group Star Dental Division
Tip holder portion of the scaler tip assembly may have an oversized condition that will not allow the scaler tip to stay seated in the holder may cause injury
Centers For Disease Control and Prevention
The H5b component may fail to amplify, resulting in an inconclusive result.
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Due to older version of Instruction for Use (IFU) instructing to ensure that the value and the sheath are tightly connected before use. This may cause users to over-tightening the luer which may result in the swivel nut detaching from the HVA body.
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
ASPEN SURGICAL
The affected products may have been packaged with a defect in the sterile barrier seal. As a result, the integrity of the sterile barrier may be compromised.
Medtronic
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Potential for coils to heat up and harm patients (burn).
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Siemens Medical Solutions USA
Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
Siemens Medical Solutions USA
Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
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.
Siemens Medical Solutions USA
Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Medtronic
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
41 mm acetabular outer heads were potentially assembled with a 42 mm locking ring, may lead to joint instability leading requiring surgical intervention
Medtronic
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Siemens Medical Solutions USA
Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
Medtronic
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
GE Healthcare Finland Oy
GE HealthCare has become aware of the potential for loss of monitoring on CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, and certain versions of CARESCAPE B850 and CARESCAPE B650 monitors if, following the replacement of the CPU timekeeper battery, a mains power loss occurs during active monitoring. In the unlikely event that this occurs, it can result in the displays or monitors not turning on, after the mains power is restored. This can result in a delay in recognizing changes in patient condition until a replacement monitor is connected.