PharmacovigilanceOfficial

Löwenstein issues field safety notice for LM150TD ventilators over possible battery communication fault

🇳🇱 IGJ · Tue 27 Oct 2026

The Dutch inspectorate IGJ has published a manufacturer warning on the LUISA, TIVAN, LS and Life One ventilator range, citing a possible communication failure of the battery.

The Dutch healthcare inspectorate IGJ has posted a field safety notice (FSN) from Löwenstein Medical Technology covering ventilators of model LM150TD. The product is listed as LUISA TIVAN LS Life One.

According to the introductory text, the manufacturer is providing urgent safety information on a possible communication failure of the battery (accu) in the device. The text says quality and safety are the company's highest priority.

The FSN is dated 6 October 2026. IGJ's download, a five-page PDF of about 409 KB, is labelled with the date 28 October 2026, one day after the date on the item. The excerpt available does not describe the failure mode, the affected serial numbers or the corrective actions. Those details sit in the PDF itself.

IGJ notes that the notice is a manufacturer warning. Manufacturers must monitor devices after they reach the market and act where users are at risk, informing users and the inspectorate through an FSN.

What it means for your team

  • Obtain and read the full five-page FSN from IGJ, as the available text gives no details on affected units or required actions.
  • Check whether LM150TD-based LUISA, TIVAN, LS or Life One ventilators are held in your inventory or used in your facilities.
  • Vigilance teams should review and record any incidents involving battery communication on these devices, and follow the manufacturer's instructions once confirmed.

Official source: IGJ ↗

Article written by VigiEye from the official source (IGJ). AI-assisted; check the source before acting.

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