All in One Bundle; Model Number: FG-BNDL-PC-REFAIO;
DAYE (ANNE'S DAY LTD)
Product lacks 510(k) clearance.
🏥 Medical Devices • 15,203 recalls
DAYE (ANNE'S DAY LTD)
Product lacks 510(k) clearance.
DAYE (ANNE'S DAY LTD)
Product lacks 510(k) clearance.
It was determined there is the potential of silicone fragments detaching from the yellow sealing component.
It was determined there is the potential of silicone fragments detaching from the yellow sealing component.
DAYE (ANNE'S DAY LTD)
Product lacks 510(k) clearance.
DAYE (ANNE'S DAY LTD)
Product lacks 510(k) clearance.
DAYE (ANNE'S DAY LTD)
Product lacks 510(k) clearance.
Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.
Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Firm is providing additional guidance for use. Expansion of RES 95214.
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Firm is providing additional guidance for use. Expansion of RES 95214.
Instructions for use for a foot plating system is being updated to remove the second option of requirements for sterilization which was 3 minutes exposure time at 134-137-degrees C (273-279-degrees F) and 40mBar for 5-10 minutes drying time, because these requirements do not apply in the United States.
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Over time some systems may experience loss of imaging functionality and/or poor image quality due to potential corrosion of the Image Intensifier Television (IITV) control board.
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
SEDECAL SA
Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.