🏥 Medical Devices • 381 recalls
Baxter Healthcare
Replacement bladder kit for the Welch Allyn two-piece reusable blood pressure cuff may contain a Large Adult size bladder rather than a Thigh size bladder in the replacement kits.
A mechanical defect on a printed circuit board (PCB) as a result of PCB separating process. This defect might cause the ventilator to either fail at startup (no patient involvement) or during the use of the device enter ambient state, resulting in an interruption of ventilation.
Philips Respironics
Devices may possess a programming error resulting in an incorrect device configuration.
Philips Respironics
Devices may possess a programming error resulting in an incorrect device configuration.
Philips Respironics
Devices may possess a programming error resulting in an incorrect device configuration.
Hamilton Medical AG
Ventilator coaxial breathing circuit may have a crack in blue tubing, which is used to deliver fresh gas to the patient. The crack will compromise inspiratory and expiratory flows, leading to partial or complete rebreathing of exhaled gases, which could lead to acute hypercapnia, respiratory acidosis, and if unrecognized organ dysfunction.
Maquet Critical Care AB
Potential for inaccurate measurement of the patient circuit compliance during the patient circuit test due to combination of incorrect pre-use leakage test and use of an incorrect active humidifier.
Philips Respironics
This device does not indicate for use in patients with respiratory failure.
Philips Respironics
This device does not indicate for use in patients with respiratory failure.
Maquet Critical Care AB
Potential for inaccurate measurement of the patient circuit compliance during the patient circuit test due to combination of incorrect pre-use leakage test and use of an incorrect active humidifier.
This device does not indicate for use in patients with respiratory failure.
Maquet Critical Care AB
Potential for inaccurate measurement of the patient circuit compliance during the patient circuit test due to combination of incorrect pre-use leakage test and use of an incorrect active humidifier.
Ventilator Printed Circuit Board Assembly may have two separate capacitors that may fail, which may result in the ventilator either shutting down during use, thus necessitating use of an alternate form of ventilation, or the shutdown alert alarm fails to alarm effectively during shut down, which may result in respiratory failure, hypoventilation, low oxygen saturation, hypoxia, treatment delay.
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.
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.
Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
The potential for cracks forming in the breathing circuit hose.
The potential for cracks forming in the breathing circuit hose.
Ventec Life Systems
Multi-Function Ventilators were serviced using incorrect parts which have the potential to cause unexpected shutdown, or when using an active circuit could result in inaccurate tidal volume monitor, not triggering on patient efforts, less inspiratory volume, less inspiratory pressure, and less PEEP delivered.