Medical equipment, implants, and diagnostic devices
Angiodynamics Inc. (Navilyst Medical Inc.)
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
There is a potential for the over-pressure safety (OPS) valve in the tubing kits to not allow flow through.
Siemens Healthcare Diagnostics
The affected lots may exhibit inaccuracy for Quality Control and patient samples at the low end of the Analytical Measurement Range. The bias is due to the calibration curve not showing separation between the Level 1 and Level 2 calibrators.
Product may fail performance testing for S aureus ATCC 43300.
There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.
Philips Electronics North America
Five warning statements are missing from the instructions for use.
Philips Medical Systems (Cleveland)
The patient support head holder could contact the back ISO shelter wall during manual or motorized motion through the gantry bore. This may result in a serious injury that would require medical intervention to preclude permanent impairment in certain scenarios.
There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.
There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.
Angiodynamics Inc. (Navilyst Medical Inc.)
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.
Siemens Healthcare Diagnostics
The affected lots may exhibit inaccuracy for Quality Control and patient samples at the low end of the Analytical Measurement Range. The bias is due to the calibration curve not showing separation between the Level 1 and Level 2 calibrators. The negative bias observed for patient, QC, and calibrator samples, when using any of the listed lots, has the potential to impact the interpretation of gentamicin results during therapeutic monitoring at concentrations up to approximately 2.5 ¿g/mL [5.4 ¿mol/L].
Angiodynamics Inc. (Navilyst Medical Inc.)
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exceeding the acceptable limits. After detection of the issue, Global Supply Chain QA asked the bioM¿rieux distributor in Guadeloupe to put products in quarantine in July 2017; After several reminders, the distributor informed in November 2017 that products were delivered to customers.
Angiodynamics Inc. (Navilyst Medical Inc.)
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
Angiodynamics Inc. (Navilyst Medical Inc.)
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
One lot of 75mm tibial tray is potentially etched and labeled as a 79 mm tibial tray. This may lead to delay in surgery, or immediate revision surgery to remove an incorrectly sized tibial component after it has been cemented.
There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.
When selecting serial radiography with a pulse rate of 7.5fps (including selecting a preset or changing the pulse rate using a temporary edit function) it was observed the indicated "irradiation time" on the X-ray Generator Console, as well as the "integral dose" on the external console of fluoroscopy, were reset to 0. There has been one report of this event.
Maquet Cardiopulmonary Ag
This lot of arterial cannula may have been supplied with 3/8-width de-airing plugs that could break during the process of removal from the arterial cannula.