Servo-n Ventilator System recall
Servo-n Ventilator System. Model Number: 6694800.
Why was Servo-n Ventilator System recalled?
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 should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model Number: 6694800. UDI-DI: 07325710001110. All software versions.
- Product
- Servo-n Ventilator System. Model Number: 6694800.
- Recalling firm
- Maquet Critical Care AB
- Quantity
- 7,688 units
- Distribution
- US Nationwide distribution and Puerto Rico. No international distribution.
- Recall date
- July 9, 2025
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)