ST SENSE Breast Dx Coil
Philips North America
Potential safety issue where a patient may be harmed while preparing for or during a scan.
95,018 total recalls in our database
Philips North America
Potential safety issue where a patient may be harmed while preparing for or during a scan.
Due to potential system error alarm and the inability to initiate therapy as a result of broken occlusion sensors.
Due to heart transmitter not being able to upgrade to the current software version in the field after experiencing a power interruption during a prior over-the-wire software download.
MEDLINE INDUSTRIES, LP - Northfield
Some of the suture packages within the convenience kits contain the incorrect needle type/size and suture diameter/length.
Smiths Medical has identified a potential for ingress of fluid into the device during reprocessing. The ingress takes place at the rear of the device between the end cap and the tube. This could lead to staining of the device or allowing the fluid to remain in the device. In addition, the Hypochlorite Solution (200ppm) and the 4% Acetic Acid disinfectants recommended in the IFU may be inadequate according to the disinfection standards for this type of device.
GE Medical Systems
Gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning.
Smiths Medical ASD
Smiths Medical has identified a potential for ingress of fluid into the device during reprocessing. The ingress takes place at the rear of the device between the end cap and the tube. This could lead to staining of the device or allowing the fluid to remain in the device. In addition, the Hypochlorite Solution (200ppm) and the 4% Acetic Acid disinfectants recommended in the IFU may be inadequate according to the disinfection standards for this type of device.
Philips North America
Potential safety issue where a patient may be harmed while preparing for or during a scan.
Baxter Healthcare
There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
Mobile x-ray system receiving/storage(operation) requirements to be followed: Temp:14 to 131(50 to 86) degrees F, RH:10% to 86%(30% to 60%) allow condensation dry time, Atmospheric Pressure:50kPa to 106 kPa(70kPa to 106kPa), Altitude:-102ft to 12,000 ft, (Maximum Gradient:9 degrees Fahrenheit), which mitigate risk of capacitor malfunction, unpredictable behavior, overheating, unintended start-up.
The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.
GE Medical Systems
Gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning.
MEDLINE INDUSTRIES, LP - Northfield
The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.
Baxter Healthcare
There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
Baxter Healthcare
There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
Within the Irish Market, that a Field Safety Notice is being issued due to a select number of authorized labelled Defibtech AED Pads, which have had the authorized label removed and an unauthorized label applied, could potentially lead to expired Defibtech AED Pads appearing as though they are within the acceptable shelf life.there is a possibility of hydrogel drying, which may result in poor electrical connection to the patient, which can reduce the energy delivered to the patient
Within the Irish Market, a Field Safety Notice is being issued due to a select number of authorized labelled Defibtech AED Pads, which have had the authorized label removed and an unauthorized label applied, could lead to expired Defibtech AED Pads appearing as though they are within the acceptable shelf life. There is a possibility of hydrogel drying, which may result in poor electrical connection to the patient, which can reduce the energy delivered to the patient.
MEDLINE INDUSTRIES, LP - Northfield
The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.
Philips North America
Potential safety issue where a patient may be harmed while preparing for or during a scan.
Baxter Healthcare
There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.