FDA Medical devices recall ·
Servo-u Ventilator System recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-2013-2025
- Date
- (initiated May 30, 2025)
- Company / brand
- Maquet Critical Care AB
Rontgenvagen 2, Solna, Sweden - Category
- Medical devices › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 874 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Servo-u Ventilator System. Model Number: 6688600.
Why was it recalled?
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 should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model Number: 6688600. UDI-DI: 07325710001042. All software versions.
Distribution
US Nationwide distribution and Puerto Rico. No international distribution.
States: Puerto Rico
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (medical devices), recall Z-2013-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.