Class I recallOngoing

Servo-n Ventilator System recall — FDA event 97032

FDA · FDA event 97032 · Posted Jun 27, 2025

Published Jun 27, 2025Updated Oct 8, 2026Source last checked: 2026-10-08 16:03:16 UTC

What happened

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.

Who may be affected

People using a product, model, software version, lot, or UDI listed in the affected-products table and official FDA record.
A mention of the device family does not mean every unit is affected. Compare the identifiers on your product with the official source.

What the official notice recommends

Maquet Critical Care AB, a subsidiary of Getinge, notified consignees on about 05/30/2025 via FedEx letter. Consignees were instructed to configure all affected Servo ventilators with "Extended leakage test" set to "Off", per chapter 8.2.4 Configuration in the User's manuals and all users are recommended to follow the updated instructions for use of the User's manuals chapter 9.5.1 Patient circuit test, which is provided. Consignees are instructed to ensure all devices in inventory have been properly addressed as described above, to ensure the message is forwarded to all affected personnel and to individuals if units were transferred. Additionally, consignees were requested to complete and return the provided response form.

The official notice takes precedence over this summary. Talk to your clinician before changing prescribed therapy.

Affected products and models

This FDA record lists Servo-n Ventilator System by Maquet Critical Care AB.

Products affected by FDA event 97032
Model	Description	Lot / serial range	Manufactured	Status
Z-2014-2025	Z-2014-2025	Model Number: 6694800. UDI-DI: 07325710001110. All software versions.	Not provided in the normalized record	Ongoing
Z-2013-2025	Z-2013-2025	Model Number: 6688600. UDI-DI: 07325710001042. All software versions.	Not provided in the normalized record	Ongoing
Z-2015-2025	Z-2015-2025	Model Number: 6888800. UDI-DI: 07325710010518. All software versions.	Not provided in the normalized record	Ongoing

Distribution: US Nationwide distribution and Puerto Rico. No international distribution.
Units affected: See official FDA record
Category: Ventilators

Timeline

May 30, 2025
Recall initiated
Date recorded by the FDA.
Jun 27, 2025
Posted by FDA
The recall event appeared in the FDA source.
Oct 8, 2026
Last checked
MedWatcher last reconciled this record with the openFDA export.

Primary source

U.S. Food and Drug Administration

Identifier: 97032
Published: Jun 27, 2025
Source checked: 2026-10-08 16:03:16 UTC

Official openFDA device-recall record. The FDA source takes precedence over this normalized summary.

View official record

How MedWatcher checks these sources

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Servo-n Ventilator System recall — FDA event 97032

FDA · FDA event 97032 · Posted Jun 27, 2025

Published Jun 27, 2025Updated Oct 8, 2026Source last checked: 2026-10-08 16:03:16 UTC

Affected products and models

This FDA record lists Servo-n Ventilator System by Maquet Critical Care AB.

Products affected by FDA event 97032
Model	Description	Lot / serial range	Manufactured	Status
Z-2014-2025	Z-2014-2025	Model Number: 6694800. UDI-DI: 07325710001110. All software versions.	Not provided in the normalized record	Ongoing
Z-2013-2025	Z-2013-2025	Model Number: 6688600. UDI-DI: 07325710001042. All software versions.	Not provided in the normalized record	Ongoing
Z-2015-2025	Z-2015-2025	Model Number: 6888800. UDI-DI: 07325710010518. All software versions.	Not provided in the normalized record	Ongoing

Distribution

US Nationwide distribution and Puerto Rico. No international distribution.

Units affected

See official FDA record

Resmed Astral 100/150 Resmed Astral 100/50 recall — FDA event 99304

Due to a Supercapacitor electrolyte leakage on Printed Circuit Board Assembly (PCBA) may damage the charger chip, causing fail-safe state and interruption of ventilation therapy.

FDA · FDA event 99304Posted Jul 28, 2026

Class II recallOngoing

VOCSN+Pro package recall — FDA event 98888

FDA · FDA event 98888Posted Jun 23, 2026

Class I recallOngoing

VOCSN V+Pro package recall — FDA event 98554

FDA · FDA event 98554Posted May 1, 2026

Servo-n Ventilator System recall — FDA event 97032

Follow Servo-n Ventilator System

What happened

Who may be affected

What the official notice recommends

Affected products and models

Timeline

Servo-n Ventilator System recall — FDA event 97032

Follow Servo-n Ventilator System

What happened

Who may be affected

What the official notice recommends

Affected products and models

Timeline

What happened

Who may be affected

What to do

What the official notice recommends

Affected products and models

Timeline

What happened

Who may be affected

What to do

What the official notice recommends

Affected products and models

Timeline