Maquet Servo-I Ventilator CO2 Analyzer Recalled for Calibration Defect
Maquet is recalling 486 Servo-I ventilator CO2 analyzers worldwide due to a calibration problem caused by an internal circuit board defect.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a functional defect (calibration) that poses a risk of harm to patients, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Maquet Cardiovascular US Sales, LLC is recalling 486 units of the Servo-I ventilator system CO2 analyzer, part number 65 23 588. The recall was initiated after a calibration problem was detected in specific models of the device.
The calibration issue may have been caused by the function of the module's internal circuit board. The affected units were distributed worldwide, including in the United States and numerous international locations such as Austria, Australia, Belgium, Canada, Germany, and the United Kingdom.
Healthcare facilities and users should check their inventory for the specific serial numbers listed in the recall notice. If a unit is affected, it should be removed from service and returned to the manufacturer or their authorized representative for evaluation and repair.
The recalled product
- Product
- Servo-I ventilator system CO2 analyzer. Part number 65 23 588.
- Manufacturer
- Maquet Cardiovascular Us Sales, Llc
- Hazard
- Affected units
- 486
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Maquet Cardiovascular Us Sales, Llc
See all →- HighMaquet Cardiovascular Recalls HLS Set Advanced Due to Sterility Breaches
FDA (Devices) · 2020-12-23
- HighMaquet Cardiovascular Recalls HLS Set Advanced Due to Sterility Breach
FDA (Devices) · 2020-12-23
- HighMaquet BMU 40 Blood Monitoring Units Recalled for Electrical Safety Non-Compliance
FDA (Devices) · 2020-11-18
- HighMaquet Yuno II Mobile Operating Table Recalled for Electric Shock Risk
FDA (Devices) · 2020-10-28
- HighMaquet Yuno Mobile Operating Table Recalled for Electric Shock Risk
FDA (Devices) · 2020-10-28
Same hazard · calibration defect
See all →- HighMedline Convenience Kits for C-Section and Obstetric Procedures
FDA (Devices) · 2026-05-13
- HighMedline Convenience Kits recalled for potential sterilization issue
FDA (Devices) · 2026-05-13
- HighMedline Neurosurgical Convenience Kits Sterilization Calibration Defect
FDA (Devices) · 2026-05-13
- ModerateMedline Convenience Kits surgical packs sterilization calibration recall
FDA (Devices) · 2026-05-13
- ModerateMedline Urology Convenience Kits recalled due to sterilization calibration issues
FDA (Devices) · 2026-05-13
Similar recalls
- SevereServo-n ventilators may measure patient circuit compliance inaccurately
FDA (Devices) · 2025-07-09
- SevereServo-u ventilators may measure patient circuit compliance inaccurately
FDA (Devices) · 2025-07-09
- SevereServo-u MR Ventilator System inaccurate patient circuit compliance measurement
FDA (Devices) · 2025-07-09
- SevereMaquet SERVO-i Ventilator Battery Modules Recalled for Shorter Run Time
FDA (Devices) · 2013-05-08
- HighMedical device blood oxygenation system recalled due to defective weld
FDA (Devices) · 2023-11-15
- ModerateMaquet Cardiohelp-I System Recalled for Potential Software Display Error
FDA (Devices) · 2014-11-19