Product Wiki · Recalls · U.S. FDA — Device Enforcement

Servo-u Ventilator System. Model Number: 6688600. — recall Z-2013-2025

U.S. FDA — Device Enforcement · Sweden · 2025-05-30 · Class I

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked on this page. No AI-generated text appears on this page. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2013-2025
Date of alert
2025-05-30
Country / jurisdiction
Sweden
Risk level
Class I
Notice type
recall
Brand
Maquet Critical Care AB
Product category
device
Product type
Devices
Recall status
Ongoing — the recall is still in progress
Initiated by
Voluntary: Firm initiated
Distribution
US Nationwide distribution and Puerto Rico. No international distribution.
Barcode (EAN/GTIN)
07325710001042
Reported risk: Potential for inaccurate measurement of the patient circuit compliance during the patient circuit test due to combination of incorrect pre-use leakage test and use of an incorrect active humidifier.
What to do

Check whether your product matches this notice (name, batch, dates). If it does, stop using it and follow the instructions in the official notice — refund, return, repair or disposal are set by the issuing authority and the business, and they differ per recall. Official notice from U.S. FDA — Device Enforcement →

Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

Related

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.