GETINGE Y SENSOR Module, SERVO-U, SERVO-N, Model Number 6693662; part of the SERVO-U/-N continuous ventilator system, fo
Summary
The FDA issued a Class II for GETINGE Y SENSOR Module, SERVO-U, SERVO-N, Model Number 6693662; part of the SER by Maquet Critical Care AB. Reason: The module did not undergo electrical safety tests and functional tests during production..
Details
Source
Device Recall
External ID
Z-2963-2026
Action Date
2026-08-26
Status
Ongoing
Category
device
Product Description
GETINGE Y SENSOR Module, SERVO-U, SERVO-N, Model Number 6693662; part of the SERVO-U/-N continuous ventilator system, for facility use. Maquet Critical Care AB, is a subsidiary of Getinge.
Lot/Code Info: DUI/DI 07325710000304, Serial/Lot Numbers: 21049, 21088, 21089, 21093, 21100, 21103 21108, 21114, 21115.
Quantity Affected: 9 units
Reason for Recall
The module did not undergo electrical safety tests and functional tests during production.
Distribution
US Nationwide distribution in the states of CA, GA, MN, NY.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-06-30
Company
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 149 device recalls issued in the same week, part of 445 device-related FDA actions this month.
Maquet Critical Care AB has 7 FDA actions in our database, including 5 recalls and 2 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
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 7 FDA actions in our database, including 5 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2963-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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