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Class IIOngoing

Maquet Critical Care AB recalls GETINGE Y SENSOR Module

Recall date · record updated Aug 26, 2026 · Source: U.S. Food and Drug Administration (openFDA device enforcement)

What to do

Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.

Company
Maquet Critical Care AB
Reason
The module did not undergo electrical safety tests and functional tests during production.
Hazard
FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).
Who’s affected
US Nationwide distribution in the states of CA, GA, MN, NY.
Where
Nationwide
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99439…

Products

  1. GETINGE Y SENSOR Module, SERVO-U, SERVO-N, Model Number 6693662; part of the SERVO-U/-N continuous ventilator system, for facility use. Maquet Critical Care AB, is a subsidiary of Getinge.

    Codes/lots: DUI/DI 07325710000304, Serial/Lot Numbers: 21049, 21088, 21089, 21093, 21100, 21103 21108, 21114, 21115.Quantity: 9 unitsRecall no. Z-2963-2026Class II

Update history

  1. First listed on OVERLOOKED from the official record.

When the agency expands or changes this recall, we update this page and log the change here.

Proof: raw official record (JSON) · fetched from FDA API

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