This recall involves updating instructions for using devices, and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without following the updated instructions.
Affected Product
- Product Names: Servo Ventilator Systems (Servo-u, Servo-n, and Servo-u MR devices)
- Model/Unique Device Identifier (UDI): 6694800/07325710001110, 6688600/07325710001042, and 6888800/07325710010518
What to Do
- All Servo-u, Servo-n, and Servo-u MR ventilators are recommended to be configured with “Extended leakage test” set to “Off”; see chapter 8.2.4 Configuration in the user’s manuals.
- All users are recommended to follow the updated instructions for use of the user’s manuals chapter 9.5.1 Patient circuit test, in appendix 1.
On May 30, 2025, Maquet Critical Care AB sent all affected customers an urgent medical device correction letter recommending the following actions:
- Ensure all affected devices in your inventory have been properly addressed.
- Ensure this message is forwarded to any individuals that need notification within your organization or any organization where the affected devices have been transferred.
Reason for Updates to Use Instructions
Maquet Critical Care AB, a subsidiary of Getinge, is updating use instructions for Servo Ventilator Systems due to risk of inaccurate compliance measurement leading to improper tidal volume delivery in neonatal patients.
The Servo ventilator systems can be used with several different patient circuits and active humidifiers. Before being used on a patient, the ventilator must pass a safety check that measures leakage, compliance, and resistance in the circuit. Some humidifiers may not pass the standard leak test due to their design, even if there’s no actual leak. To address this, there is an optional configuration for the ventilator with an “Extended leakage test” in the ventilator’s Service & Settings menu.
This extended test should only be used with humidifiers that cannot pass the standard leak test. If a hospital uses multiple types of humidifiers, there’s a risk that the ventilator could be set to the wrong test for the humidifier in use.
If a ventilator is configured for the extended leakage test but used with an active humidifier that doesn’t require it, it may result in:
- In Pressure Control mode: The displayed tidal volume may be higher than the volume actually delivered.
- In PRVC mode: The ventilator may deliver a lower tidal volume than what is set and displayed.
When using tidal volumes of 5 mL or less in PRVC mode, there can be up to a 50% difference between the displayed and actual delivered volume. This may lead to hypoventilation and hypoxia, though these issues should be detected by external monitoring and alarms.
The use of affected product may cause serious adverse health consequences, including not enough oxygen (hypoxia) and too much carbon dioxide (hypercapnia) in extremely premature neonates.
There has been one reported injury. There have been no reports of death.
Device Use
A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
The Servo-u Ventilator System is:
- intended for respiratory support, monitoring, and treatment of neonatal, pediatric, and adult patients
- to be used only by healthcare providers
- to be used only in professional healthcare facilities and for transport within these facilities
The Servo-n Ventilator System is:
- intended for respiratory support, monitoring, and treatment of neonatal and pediatric patients
- to be used only by healthcare providers
- to be used only in professional healthcare facilities and for transport within these facilities
The Servo-u MR Ventilator System is:
- intended for respiratory support, monitoring, and treatment of neonatal, pediatric and adult patients
- to be used only by healthcare providers
- to be used only in professional healthcare facilities and for transport within these facilities
- to be used in MR environment according to specified conditions
- with 1.5 T or 3 T MR scanners
- outside magnetic fields >20 mT/200 Gauss
Contact Information
Customers in the U.S. with questions about this recall should contact technical services at 1-888-943-8872, Option 4, Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. ET
Additional FDA Resources:
Unique Device Identifier (UDI)
The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
