Summary
The FDA issued a Class I for Servo-n Ventilator System. Model Number: 6694800. by Maquet Critical Care AB. Reason: Potential for inaccurate measurement of the patient circuit compliance during the patient circuit test due to combination of incorrect pre-use leakage.
Details
Source
Device Recall
External ID
Z-2014-2025
Action Date
2025-07-09
Status
Ongoing
Category
device
Product Description
Servo-n Ventilator System. Model Number: 6694800.
Lot/Code Info: Model Number: 6694800. UDI-DI: 07325710001110. All software versions.
Quantity Affected: 7,688 units
Reason for Recall
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.
Distribution
US Nationwide distribution and Puerto Rico. No international distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-05-30
Company
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 153 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Maquet Critical Care AB has 4 FDA actions in our database, including 3 recalls and 1 clearance.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Maquet Critical Care AB) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Maquet Critical Care AB have FDA actions?
Maquet Critical Care AB has 4 FDA actions in our database, including 3 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2014-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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