Food, drugs, devices › Maquet Critical Care AB
Device recall: Servo-u Ventilator System. Model Number: 6688600.
Maquet Critical Care AB (Solna) initiated this device recall on 30 May 2025; FDA lists 3 product records under event 97032, classified Class I.
FDA defines Class I as a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. 13% of the 945 device enforcement events initiated in 2025 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Maquet Critical Care AB has 3 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Maquet Critical Care AB, Solna, Sweden.
Reason for recall
"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."
Distribution
"US Nationwide distribution and Puerto Rico. No international distribution."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2013-2025 | Servo-u Ventilator System. Model Number: 6688600. | 874 units | Class I | Ongoing | 9 Jul 2025 |
| Z-2014-2025 | Servo-n Ventilator System. Model Number: 6694800. | 7,688 units | Class I | Ongoing | 9 Jul 2025 |
| Z-2015-2025 | Servo-u MR Ventilator System. Model Number: 6888800. | 129 units | Class I | Ongoing | 9 Jul 2025 |
Context
Other enforcement events for Maquet Critical Care AB
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 30 Jun 2026 | GETINGE Y SENSOR Module, SERVO-U, SERVO-N, Model Number 6693662; part of the SERVO-U/-N continuous ventilator system, fo | Device | Class II | 1 |
| 24 Jun 2026 | Flow Anesthesia Machine Flow-i C20 6677200 Flow-i C30 6677300 Flow-i C40 6677400 Flow-i C20 6888520 Flow-i C30 6888530 F | Device | Class II | 1 |
All 3 events for Maquet Critical Care AB
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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 does Class I mean?
FDA classifies recalls by relative degree of health hazard. Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
Where was the product distributed?
FDA's distribution pattern field reads: "US Nationwide distribution and Puerto Rico. No international distribution."
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.