Medical equipment, implants, and diagnostic devices
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.
Potential for DC Power Supply housing to become hot to the touch and deform the plastic housing.
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.
ICU Medical
Firm has identified Drug Library Management defects in the software: 1) DLM software does not allow user to create percentage dose rate or rate change values with certain limits, potentially resulting in over-delivery to patient. 2) An unauthorized user may modify and approve a drug library, potentially leading to incorrect program parameters being used for therapy.
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.
Due to mislabeling of products
An issue with a raw material used to coat some surgical needles that may result in diminished performance and/or removal of some silicone needle coating during use.
LeMaitre Vascular
During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier).
During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier).
Nipro Renal Soultions USA
Potential for the presence of visible foreign matter.
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.
The perc pin adaptor AMCH07200 tightening knob was found to be inconvenient to the user and the tightening markings found to be improperly placed.
Potential for microbial contamination.
Contec Medical Systems Co.
Patient monitor has nine identified cybersecurity vulnerabilities.
A cybersecurity vulnerability was discovered through internal testing.
Adapters may disconnect during setup or while in use, potentially interrupting ventilation. Any disconnection can result in severe consequences for neonates, including hypoxia, hypercapnia, and organ failure.
During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier).
MEDLINE INDUSTRIES, LP - Northfield
Three is the potential for the retractors to puncture through the sterile packaging.
Disconnection of the adapter from the endotracheal tube can potentially be difficult or not possible.