GE Healthcare has become aware of a potential issue on 800 family NM/CT Scanners that could cause a shift in CT radiation exposure range of up to 5cm compared to the intended radiation exposure range of the planned scan under specific workflows. The issue occurs only on a hybrid whole-body continuous F3 protocol with Zoom < 1 where the scan range is set on the Smart Console. In some cases, this may also necessitate a re-scan of the patient, which would expose the patient to additional X-ray radiation.
Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
St. Jude Medical, Cardian Rhythm Management Division
🏥 Medical Devices Class I - Dangerous
Due to a manufacturing issue associated with the mixing process of the epoxy used in the manufacture of pacemaker from years 2015 through 2018, the affected devices may malfunction caused by moisture ingress through the device header and feedthrough
The products contain sodium hydroxide, which must be in child resistant packaging as required by the Poison Prevention Packaging Act (PPPA). The packaging of the products is not child resistant, posing a risk of chemical burns and irritation to the skin and eyes. In addition, the label on the products violate the Federal Hazardous Substance Act (FHSA) by omitting the word "poison" and other mandatory information on the packaging.
The vehicles were manufactured without copper seal washers on the turbocharger’s oil supply line, which can result in an oil leak, posing a fire hazard.
The products contain sodium and potassium hydroxide, which must be in child resistant packaging as required by the Poison Prevention Packaging Act (PPPA). The packaging of the products is not child resistant, posing a risk of chemical burns and irritation to the skin and eyes. In addition, the label on the products violates the Federal Hazardous Substance Act (FHSA) by omitting the word "poison" and other mandatory information on the packaging.
Ingredients statement declares Unsalted Cream but does not list milk. Label has allergen advisory statement "Mfg on same equipment that processes wheat, egg, peanut & tree nut. May contain traces of soy, milk, peanuts & tree nuts".