Servo-u MR Ventilator System inaccurate patient circuit compliance measurement
Servo-u MR Ventilator System (Model 6888800) may measure patient circuit compliance inaccurately due to incorrect pre-use leakage testing and incorrect active humidifier use.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall of a critical medical device (ventilator) that directly affects patient safety by potentially providing inaccurate measurements during clinical use. Although no reported illnesses or injuries are stated in the source, the defect in a life-support device measuring system meets the Class I definition and warrants a Severe classification.
Plain-English summary
Maquet Critical Care AB is recalling the Servo-u MR Ventilator System, Model Number 6888800, distributed nationwide in the US and Puerto Rico. The ventilator may provide inaccurate measurement of patient circuit compliance during the patient circuit test when an incorrect pre-use leakage test is performed in combination with use of an incorrect active humidifier.
Inaccurate compliance measurements could affect the proper functioning of the ventilator. All software versions of the affected model are included in this recall. A total of 129 units have been distributed.
Facilities and healthcare providers currently using this ventilator model should contact Maquet Critical Care AB for guidance on corrective actions, which may include software updates, equipment repair, or replacement. Clinicians should verify proper pre-use testing procedures and humidifier configuration to ensure accurate patient circuit compliance measurements.
The recalled product
- Product
- Servo-u MR Ventilator System. Model Number: 6888800.
- Manufacturer
- Maquet Critical Care AB
- Category
- Medical Device — Ventilator
- Hazard
- inaccurate-measurement
- measurement-error
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Model Number: 6888800. UDI-DI: 07325710010518. All software versions.
Distribution
Distributed nationwide across the United States.
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