GE HealthCare warns Carestation 850 anaesthesia systems may under-deliver vapour versus set concentration
The Dutch inspectorate IGJ has published a manufacturer field safety notice saying certain Carestation 850 and 850c units may release less anaesthetic vapour than the user selects.
The Dutch Health and Youth Care Inspectorate (IGJ) has published a manufacturer warning on the Datex-Ohmeda Carestation 850, after GE HealthCare found that certain Carestation 850 and 850c anaesthesia systems can deliver less anaesthetic vapour than the concentration chosen by the user.
The notice is a Field Safety Notice (FSN) dated 3 November 2026. The IGJ item is dated 9 November 2026, and the English-language PDF of the warning is labelled 10 November 2026. The manufacturer is listed as Datex-Ohmeda, Inc. The PDF runs to four pages. The affected products are listed in a details section of the notice, which the IGJ page text does not reproduce.
The IGJ page does not set out the cause of the fault, the number of units involved or the corrective steps. Those details are in the manufacturer's document. The inspectorate does not say whether any patient harm has been reported.
The IGJ explains that manufacturers must monitor their devices after they reach the market and improve them where needed. Where a risk to users arises, the manufacturer must act and tell both users and the inspectorate through a Field Safety Notice. The notice falls under the IGJ's oversight of medical technology.
What it means for your team
- Hospitals and anaesthesia departments using Carestation 850 or 850c systems should check the product list in the FSN against their installed base and follow the manufacturer's instructions.
- Quality and biomedical engineering teams should log the FSN and record which units are affected and what action was taken.
- Vigilance teams should note that the FSN is dated 3 November 2026, and that the IGJ published it on 9 November 2026.
- Teams should consult the full four-page PDF for the affected models and corrective actions, as the IGJ summary does not give them.
Article written by VigiEye from the official source (IGJ). AI-assisted; check the source before acting.
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