Servo-n ventilators may measure patient circuit compliance inaccurately
The Servo-n Ventilator System is being recalled because patient circuit compliance may be measured inaccurately during the patient circuit test. 7,688 units affected.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I recall, which the rubric floors at Severe; no death or injury is reported in the source, so it does not escalate to Critical.
Plain-English summary
The Servo-n Ventilator System, model number 6694800, UDI-DI 07325710001110, from Maquet Critical Care AB, is being recalled across all software versions. The action covers 7,688 units.
The stated reason is the potential for inaccurate measurement of the patient circuit compliance during the patient circuit test, due to a combination of an incorrect pre-use leakage test and use of an incorrect active humidifier. The FDA classified the action as Class I, its most serious classification.
Distribution was nationwide in the United States and Puerto Rico, with no international distribution.
Facilities should identify affected units using the model number and UDI-DI above and follow the instructions issued by the manufacturer.
The recalled product
- Product
- Servo-n Ventilator System. Model Number: 6694800.
- Manufacturer
- Maquet Critical Care AB
- Category
- Medical Device — Ventilator
- Affected units
- 7,688
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: 6694800. UDI-DI: 07325710001110. All software versions.
Distribution
Part of a larger recall action
This product is one of 3 recalled by Maquet Critical Care AB under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
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