Dutch inspectorate publishes Intersurgical spirometry and anaesthetic breathing system field safety notice
IGJ has posted a manufacturer warning after market reports of abnormal waveforms and inaccurate physiological measurements, with an investigation pointing to gaps in Intersurgical's internal testing.
The Dutch Health and Youth Care Inspectorate (IGJ) has published a manufacturer warning covering Intersurgical spirometry sets and anaesthetic breathing systems. The notice carries a date of 9 November 2026 on the IGJ site, while the manufacturer's field safety notice (FSN) is dated 12 October 2026.
According to the IGJ summary, the company received reports from the market of abnormal waveform performance and inaccurate physiological measurements. An investigation then identified limitations in the existing internal test protocol, which may not reliably detect certain assembly and functional defects.
The manufacturer is Intersurgical Ltd, with UAB Intersurgical named as its authorised representative. The IGJ page links to an English-language PDF of seven pages. The text available here does not describe the corrective actions, nor does it identify affected products, lots or quantities, so readers will need to consult the full notice.
IGJ stresses that this is a warning issued by the manufacturer, not an inspectorate decision. As context, manufacturers must monitor devices after they reach the market. Where a risk to users arises, they must act and inform both users and the authority through a field safety notice.
What it means for your team
- Hospitals and anaesthesia departments using Intersurgical spirometry sets or anaesthetic breathing systems should read the full FSN to determine whether their products are affected and what action is requested.
- Quality teams should note that the stated root issue concerns the manufacturer's internal test protocol and its ability to detect assembly-related defects, which may be relevant to supplier-oversight reviews.
- Vigilance and risk managers should check local incident records for abnormal waveform or inaccurate measurement reports involving these products.
- Lot numbers and specific corrective measures are not stated in the IGJ summary, so no scope assumptions should be made without the PDF.
Article written by VigiEye from the official source (IGJ). AI-assisted; check the source before acting.
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