Medical equipment, implants, and diagnostic devices
ROUTE 92 MEDICAL
Their is the potential for distal tip separation at the proximal marker band of the delivery catheters.
Howmedica Osteonics
The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
Siemens Medical Solutions USA
On ultrasound systems, when Cardiac DICOM SR feature is configured to display either minimum or maximum measured value, and multiple cardiac region measurements are made, and results are exported into the SR feature, then The SR viewer will display the LAST measured value, not min or max, which could contribute to patient condition misdiagnosis or negatively influence patient management decisions.
Howmedica Osteonics
The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
Their is the potential for distal tip separation at the proximal marker band of the delivery catheters
There are two windows on the test device, the control line window and the test results window. The line for the test results window were misaligned. In instances of positive test results, the positivite test line may not be visible/ hidden under the cassette of the test device thus potentially leading to a false negative result.
Parker Laboratories
Product demonstrates low viscosity.
Possible failure of Uninterruptable Power Supply (UPS) devices supporting the Patient Information Center (PIC) iX system, potential for the associated PIC iX system to shut down due to the lack of power. may lead to the delay in the detection of a change in a patient condition
Howmedica Osteonics
The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
3M Company - Health Care Business
Select lots of the 3M Durapore Surgical Tape, Catalog Number 1538-118, were incorrectly labeled with a shelf life of 5 years, rather than 3 years.
Howmedica Osteonics
The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
Howmedica Osteonics
The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead to no therapeutic treatment signal being delivered to the electrodes, and result in delay of treatment
Due to complaints of particulates, residue, occlusions, and bent tips for sterile cannulas.
Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead to no therapeutic treatment signal being delivered to the electrodes, and result in delay of treatment
Received complaints that bottles assembled with one batch of bottle collars can be disassembled in two parts when used under pressure (during treatment or storage if the use is not releasing the pressure inside the bottles).
There are two windows on the test device, the control line window and the test results window. The line for the test results window were misaligned. In instances of positive test results, the positivite test line may not be visible/ hidden under the cassette of the test device thus potentially leading to a false negative result.
Siemens Medical Solutions USA
On ultrasound systems, when Cardiac DICOM SR feature is configured to display either minimum or maximum measured value, and multiple cardiac region measurements are made, and results are exported into the SR feature, then The SR viewer will display the LAST measured value, not min or max, which could contribute to patient condition misdiagnosis or negatively influence patient management decisions.
Products may not be heparin coated as indicated on the label-leads to a potential loss of benefit due to the absence of the heparin coating
Philips North America
Patient support table floor plate may be incorrectly installed.