Maquet Critical Care AB medical device recall: Servo-u Ventilator System. Model Number: 6688600
Key facts
- Agency
- U.S. Food and Drug Administration (FDA)
- Program
- Medical devices
- Classification
- Class I
- Status
- Ongoing
- Event ID
- 97032
- Recall initiated
- May 30, 2025
- Classified by FDA
- Jun 27, 2025
- Posted in Enforcement Report
- Jul 9, 2025
- Recalling firm
- Maquet Critical Care AB
- Firm location
- Solna, Sweden
- Initiated by
- Voluntary: Firm initiated
- Firm notified customers by
- Letter
- Products in this event
- 3
What to do
Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.
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.
What the classification means
- Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.
About this recall
The firm started this recall on May 30, 2025. FDA classified it 28 days later, on Jun 27, 2025. This recall event covers 3 separate products, each with its own FDA recall number. Distribution reported by FDA: US Nationwide distribution and Puerto Rico. No international distribution. Maquet Critical Care AB has 3 recalls in our records.
Recalled products (3)
Z-2013-2025 Class I Ongoing
Servo-u Ventilator System. Model Number: 6688600.
Codes / lots: Model Number: 6688600. UDI-DI: 07325710001042. All software versions.
Quantity: 874 units
Z-2014-2025 Class I Ongoing
Servo-n Ventilator System. Model Number: 6694800.
Codes / lots: Model Number: 6694800. UDI-DI: 07325710001110. All software versions.
Quantity: 7,688 units
Z-2015-2025 Class I Ongoing
Servo-u MR Ventilator System. Model Number: 6888800.
Codes / lots: Model Number: 6888800. UDI-DI: 07325710010518. All software versions.
Quantity: 129 units
Source and freshness
- Source
- U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA device enforcement dataset
- Official notice
- FDA Enforcement Report, event 97032
- Raw record
- openFDA API (JSON)
- Dataset last updated by FDA
- Nov 3, 2026
- Imported by RecallRadar
- Nov 4, 2026
Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.