Maquet recalls Servo-u MR Ventilator Model 6888800 due to potential inaccurate patient circuit compliance measurements during tests, affecting ventilator safety.
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.
Maquet is recalling its Servo-u MR Ventilator System (model 6888800) because incorrect pre-use leakage tests combined with an improper humidifier can lead to inaccurate circuit compliance measurements during patient tests. This could cause unsafe ventilation settings if not corrected.
The ventilator may give incorrect readings about how well the patient's airway works during a test. This happens when the pre-use leakage test is done wrong or the wrong humidifier is used. Inaccurate readings could lead to unsafe ventilation settings.
Healthcare providers using the Servo-u MR Ventilator System model 6888800 are affected. Patients on ventilators with this model are at risk if the compliance test is inaccurate.
Check for the model number 6888800 on the ventilator. The product was sold with all software versions and has a UDI-DI code 07325710010518.
Look for the model number 6888800 on the ventilator or its documentation.
The ventilator may have inaccurate circuit compliance measurements if the pre-use leakage test is incorrect or the wrong humidifier is used. Users should check the model number and follow the recall instructions.
The recall does not specify a remedy. Check the model number and contact Maquet if you have the affected model.
Look for the model number 6888800 on the ventilator. The product was sold with all software versions and has a UDI-DI code 07325710010518.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-2015-2025 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-2015-2025 from Maquet. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.