Servo-u MR Ventilator System recalled for potential measurement inaccuracy
Maquet Critical Care is recalling the Servo-u MR Ventilator System (Model 6888800) due to potential inaccuracy in patient circuit compliance measurement. The issue affects 129 units distributed nationwide in the US and Puerto Rico.
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: FDA Class I classification mandates a minimum severity score of 4. The recall involves a critical respiratory device with potential measurement inaccuracy. No illnesses or injuries are reported in the source, so the score does not reach critical (5).
Plain-English summary
Maquet Critical Care AB is recalling the Servo-u MR Ventilator System (Model 6888800) due to potential inaccuracy in measuring patient circuit compliance during pre-use testing. The recall affects 129 units distributed nationwide in the US and Puerto Rico.
The hazard arises from a combination of an incorrect pre-use leakage test and the use of an incorrect active humidifier. These conditions can lead to inaccurate patient circuit compliance measurements, which may affect proper ventilator function and patient safety.
Affected healthcare facilities should discontinue use of recalled units and contact Maquet Critical Care AB for replacement or updated guidance. Verify your equipment's Model Number (6888800) and UDI-DI (07325710010518) to determine if your ventilator is subject to this recall.
The recalled product
- Product
- Servo-u MR Ventilator System. Model Number: 6888800.
- Manufacturer
- Maquet Critical Care AB
- Hazard
- inaccurate-measurement
- equipment-malfunction
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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