95,018 total recalls in our database
Aizu Olympus Co.
Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection
Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection
Sentinel CH SpA
A high recovery of Iron assay has been observed at some customer sites. Internal studies confirmed the positive shift of Quality Control and patient samples results, up to 15% for Iron Products (Alinity c Iron Reagent REF. 08P3920) to be used on Abbott Alinity Instrument and to 30% for Iron Products (IRON REF. 6K95-41 and IRON REF. 6K95- 30) to be used on Abbott Architect Instrument. When using the affected lots, there is a potential for delay in reporting patient results due to QC failure, also a potential for falsely elevated results.
Philips North America
Potential component failure in the Gradient Coil could product smoke and/or fire.
A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
LEONI CIA CABLE SYSTEMS
Users of the patient positioning system ORION System can be faced with a sudden short-term acceleration or with an unintended short-distance movement when the movements are again allowed after an unforeseen interruption signal of motion may result in a collision of the patient with another stationary component of the treatment room.
Philips North America
Potential component failure in the Gradient Coil could product smoke and/or fire.
Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
Affected infusion sets labeled as free of DEHP actually do contain di(2-ethylhexyl) phthalate (DEHP).
Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection
Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection
A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection
Philips North America
Potential component failure in the Gradient Coil could product smoke and/or fire.
Aizu Olympus Co.
Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection
A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
Unomedical A/S
The Varisoft infusion set is used in conjunction with tandem insulin pumps. The defect reported was damage to the connector piece during manufacturing. This damage results in the connector becoming detached more easily from the insulin set than expected, requiring less force to disconnect than intended. Disconnection, when not detected, for example during sleep, leads to missed basal dosing. which in turn can result in elevated blood glucose and ketone level (nocturnal hyperglycemia). Diabetic ketoacidosis.
Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection
Philips North America
Potential component failure in the Gradient Coil could product smoke and/or fire.
Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery