GETINGE Y SENSOR Module Recall Over Missing Electrical Safety Tests
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Maquet Critical Care AB is recalling 9 GETINGE Y SENSOR Modules for SERVO-U and SERVO-N ventilators because they did not undergo required electrical safety and functional tests.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on September 10, 2026 and geographically references United States. The FDA classifies this as a Class II recall, with the stated reason "The module did not undergo electrical safety tests and functional tests during production.", distributed us nationwide distribution in the states of ca, ga, mn, ny.. FDA recall classes run from I (reasonable probability of serious harm) to III (unlikely to cause harm), so the class number is the fastest way to gauge severity here. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.
What Happened
Maquet Critical Care AB initiated a recall because the GETINGE Y SENSOR Module did not undergo electrical safety tests and functional tests during production.
Which Products Are Affected
The recall involves the GETINGE Y SENSOR Module, SERVO-U, SERVO-N, Model Number 6693662, part of the SERVO-U/-N continuous ventilator system. A total of 9 units are affected, distributed to US Nationwide in the states of CA, GA, MN, NY. The DUI/DI is 07325710000304. Affected serial/lot numbers are: 21049, 21088, 21089, 21093, 21100, 21103, 21108, 21114, 21115. The recall number is Z-2963-2026.
What You Should Do
Facilities should identify affected units using the provided serial numbers.
Why This Matters
The recall affects ventilator system components distributed across multiple states.
Source
https://www.fda.gov Event ID 99439, Recall Number Z-2963-2026, Maquet Critical Care AB.
Original source: FDA Official Notice ↗
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Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (931 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to September 10, 2026.
Frequently Asked Questions
Common questions about this FDA recall.