Ventec Life Systems, Inc. — Class I: VOCSN (Japan) Model Number: PRT-01100-100, Package PN:PRT-01126-100. used for ventilator
Ventec Life Systems has issued a Class I recall for the VOCSN (Japan) ventilator due to a defect where the internal flow transducer cable connector may disconnect from the internal board. This disconnection can lead to a system reboot and a subsequent interruption of ventilation therapy.
This recall affects Ventec Life Systems, healthcare facilities utilizing the VOCSN (Japan) model, and quality/manufacturing departments responsible for ventilator hardware assembly and internal component security.
A Class I designation indicates the FDA believes the defect poses a significant risk of serious injury or death. The potential for sudden interruption of life-sustaining ventilation therapy without warning necessitated this high-level enforcement action. This suggests a mechanical failure in the assembly or design of the internal connector that fails to withstand normal operating conditions or transport.
QA and Engineering teams should evaluate internal connection integrity and connector locking mechanisms for critical life-support devices. Regulatory teams should monitor for similar failures in other regions if the device is marketed globally, and ensure CAPA plans address the mechanical stability of internal components.
Class I. Reason: Ventilator's Internal Flow transducer cable connector may disconnect from internal board, potentially resulting in system reboot and interruption of ventilation therapy.. Product: VOCSN (Japan) Model Number: PRT-01100-100, Package PN:PRT-01126-100. used for ventilatory support.. Firm: Ventec Life Systems, Inc. (Bothell WA United States). Status: Ongoing.
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