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.
What this means for you
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.
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