Hamilton Medical issues alert for breathing circuit sets after reports of valve failures. FDA has issued an early alert regarding certain coaxial breathing circuit sets manufactured by Hamilton Medical after reports of expiratory valve malfunctions that have resulted in four serious injuries. Claire Wallace, Senior Writer, Informa Markets - Engineering June 10, 2026 On May 18, Hamilton Medical sent letters to affected customers warning that certain lots of coaxial breathing circuit sets used with HAMILTON-C1, HAMILTON T-1, and HAMILTON-MR1 ventilators may not perform as intended due to expiratory valve membrane adhesion issues. According to Hamilton Medical, the expiratory valve membrane in some units adhered to the sealing ring on the body of the expiratory valve, impairing valve opening and expiratory gas flow. The issue is not detected during the standard pre-operative test of the ventilator unless a test lung is actively ventilated. When the expiratory valve membrane adheres to the sealing ring, the malfunction typically appears within the first breaths after ventilation is initiated. When expiratory gas flow is impeded, the end-expiratory pressure becomes too high or the end-expiratory flow becomes too low, triggering the ventilator's "Exhalation Obstructed" alarm. An obstruction of expiratory flow results in inadequate ventilation and impaired gas exchange. Acute respiratory compromise due to impaired exhalation may result in inadequate ventilation and oxygen desaturation, also known as hypoxemia. As of May 13, Hamilton Medical reported four serious injuries and no deaths associated with this issue. The affected devices include: T1 CIRCUIT 240 +VALVE B/10 (Product Number: 260127) T1 CIRCUIT 180 +VALVE B/20 (Product Number: 260128) MR1 CIRCUIT 300 +VALVE B/10 (Product Number: 260167) MR1 CIRCUIT 480 +VALVE B/8 (Product Number: 260168) All affected products are Hamilton Breathing circuit sets, coaxial, preassembled with an expiratory valve set. Hamilton Medical is recommending that users verify unimpeded expiratory gas flow prior to use by ventilating a test lung using specific settings provided by the company after performing the pre-operative test. "If no 'exhalation obstruction' alarm is issued, the expiratory valve is safe to use," the company stated in its customer letter. "If the 'exhalation obstruction' alarm is triggered, do not use the coaxial breathing circuit set. The coaxial breathing circuit set must be discarded and replaced." If the "Exhalation Obstructed" alarm is triggered during patient use, Hamilton Medical recommends users disconnect the patient from the ventilator and ensure alternative means of ventilation, such as an alternative ventilator or hand bagging. Healthcare facilities are advised to inform all potential users of affected coaxial breathing circuit sets about this issue and post the provided notice. Affected products may continue to be used with the risk mitigations provided. Hamilton Medical ventilator coaxial breathing circuits are intended to connect HAMILTON-C1/T1/MR1 ventilators to a patient tube or respiratory mask during ventilation. FDA stated it is currently reviewing information about this potentially high-risk device issue and will keep the public informed as significant new information becomes available. In August, Hamilton Medical AG issued a correction for HAMILTON-C6 ventilators due to a risk of ventilation interruption from defective circuit boards, but no deaths or injuries were reported. Hamilton has been relatively free of recalls the last several years, but in 2024, the company corrected software for its Hamilton-C6 ventilator after one reported injury and one report of death. At the end of 2023, the company recalled its Hamilton C1/T1/MR-1 ventilators after degrading capacitors on the control board and spare parts leaked electrolyte fluid onto the control board, potentially causing a short circuit, and recalled its C1, C2, C3, and T1 ventilators with the neonatal option installed following software issues that could cause the machines to stop ventilating without notice. Senior Writer, Informa Markets - Engineering Claire Wallace is a senior staff writer at Medical Device + Diagnostics Industry (MD+DI), where she covers key developments in the healthcare and medical device industry. With nearly a decade of journalism experience, she brings a deep understanding of the healthcare industry and a proven ability to connect with physicians, medtech leaders, and policy experts on the issues shaping care delivery today. She is committed to delivering nuanced coverage that helps industry professionals anticipate trends, understand regulatory shifts, and identify opportunities in an increasingly complex healthcare ecosystem. Before joining MD+DI, Claire spent three years at Becker's Healthcare as a writer and assistant editor, leading coverage on developments across orthopedics, outpatient care, cardiology, and gastroenterology that bridged perspectives from clinicians and healthcare executives. Her reporting background also includes lifestyle, political, and clean energy news, with bylines in various national and digital publications. Claire earned her bachelor's degree in Communications and Media & Screen Studies from Northeastern University, where she also minored in Political Science and Journalism. She holds a master's degree in Media Advocacy and is currently based in Chicago. Want more MD+DI in your search results? Editors' choice. Sponsored Content Jun 11, 2026 Sponsored Content Jun 11, 2026 Sponsored Content Jun 11, 2026

Hamilton Medical selects PTC for Application Lifecycle Management. PTC's Codebeamer Application Lifecycle Management (ALM) solution has been selected by Hamilton Medical to replace the company's legacy ALM system and paper-based processes. The global ventilator manufacturer, already a long-term user of PTC's Windchill Product Lifecycle Management (PLM) platform, made the transition to strengthen collaboration across engineering, risk management, quality, and verification and validation teams. Enhancing traceability and compliance. The Codebeamer platform enables automated traceability and audit readiness throughout product development, supporting compliance with stringent medical device regulations. Used alongside Windchill, the two systems create a unified product data foundation that connects requirements, testing activities, and release decisions, offering end-to-end visibility across the development lifecycle. Long-Term collaboration and integration. Under a multi-year agreement, Hamilton Medical and PTC will work together to develop standardised medical technology software capabilities and advance integration between Codebeamer and Windchill. Hamilton Medical will contribute its expertise in critical device development processes, methodologies, and tool usage. These insights will help PTC refine its market-specific standards and enhance its out-of-the-box ALM and PLM solutions to support seamless, end-to-end product development aligned with the company's Integrated Product Engineering (IPE) objectives. Industry perspective. "This collaboration positions us at the forefront of industry-specific software development," said Jim Giger, Director of Research and Development at Hamilton Medical. "Given the critical role our products play in patient care, our development processes must be both uncompromisingly rigorous and highly adaptable. PTC's ALM solution empowers us to adhere to risk-centric development practices while retaining the flexibility to respond to evolving product and regulatory demands, ultimately supporting safe, scalable innovation across our portfolio." PTC's broader vision. PTC says Codebeamer, Windchill and the wider portfolio support its vision for the Intelligent Product Lifecycle, enabling manufacturers to build a strong engineering data foundation, extend that data across the enterprise, and drive AI-enabled transformation. Broader use of product data, the company notes, helps organisations accelerate time-to-market, improve product quality, manage complexity, and meet regulatory requirements.