🏥 Medical Devices • 15,203 recalls
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.
A cybersecurity vulnerability was discovered through internal testing.
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.
Philips Medical Systems Nederland B.V.
An issue was identified with the software when using the Echo Module of ISCV, the issue may result in missing or incomplete information in the report.
Potential for exoskeleton to lose lateral balance and cause patient to fall.
Integra LifeSciences Corp. (NeuroSciences)
Inadequate weld that can potentially cause the product to disassemble.
Inari Medical - Oak Canyon
Thrombectomy device specifies vessel range of 2.5-6 mm on the pouch, carton, and Instructions for Use rather than the correct vessel range of 3-6 mm, which could incrementally increase the radial force on the artery, which has the potential of vascular complications.
Getinge Disinfection Ab
The frequency inverter is not programmed by supplier according to specification which causes the circulation pump to start earlier than expected, resulting in additional wear and tear, earlier than expected, on the axial seal in the pump housing.
SCIENCE & BIO MATERIALS
Vials of implant bone granules may contain less product then specified on labeling.
Bausch & Lomb Surgical
In response to an increased number of reports of toxic anterior segment syndrome (TASS) in conjunction with implantation of enVista Aspire and enVista Envy IOLs, and certain enVista monofocal lenses in the U.S.
Getinge Disinfection Ab
The frequency inverter is not programmed by supplier according to specification which causes the circulation pump to start earlier than expected, resulting in additional wear and tear, earlier than expected, on the axial seal in the pump housing.
Integra LifeSciences Corp. (NeuroSciences)
Inadequate weld that can potentially cause the product to disassemble.
In response to an increased number of reports of toxic anterior segment syndrome (TASS) in conjunction with implantation of enVista Aspire and enVista Envy IOLs, and certain enVista monofocal lenses in the U.S.
Incorrect labeling in which the front red pouch label did not match the actual size of the medical device. The label on the front of the scope incorrectly states 5.0/2.2 while the back label, shipping box and product inside correctly states 5.6/2.8.
GE Medical Systems China Co.
GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation.
GE Medical Systems China Co.
GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Delivery Systems will not provide effective ventilation in Volume Control Ventilation (VCV) mode. In these systems, effective ventilation can be achieved in Pressure Control Ventilation (PCV) or Pressure Control Ventilation Volume Guarantee (PCV-VG) modes or with Manual ventilation.
IBA Dosimetry GmbH
Wrong analysis results can occur if the user creates two structures with the same name, except for one differing by a special character.
The device was delivered with a preassembled Femoral Augment screw that was missing its thread.